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Report on Cellulite reduction treatments through Dermoelectroporation

Dr. Suneil Jain, N.M.D.

Scottsdale Natural Medicine and Healing Clinic, LLC, 8390 E. Via de Ventura Blvd. Suite F-111 Scottsdale, AZ 85258

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of a cellulite reduction cocktail on Thighs, Abdomen, Gluteus & Knees through Dermoelectroporation®.

Study Design

  • Grades 1-2, some 3 were treated
  • Treatments should be administered every 2 weeks.
  • Average number of treatments 5-8.
  • Hyaluronidase /L-Carnitine/Phosphatidylcholine cocktail was delivered
  • Ultrapeel® Transderm® Meso System
  • Session number depending on the single patient's condition
  • Study conclusion on 90% or more resolution of the affected sites

 

Materials and Methods

Materials

  1. L-Carnitine - plays an important role in fat metabolism;
    shuttles long chain fatty acids across the mitochondrial
    membrane, once inside stimulates beta oxidation
  2. Phosphatidylcholine - penetrates the adipose cell, acts
    as a fat emulsifier by altering the stored lipids making them
    water soluble
  3. Hyaluronidase - naturally occurring enzyme that helps
    break up connective tissue bonds that create dimpling
    effect
  4. Ultrapeel® Transderm Meso® system from Mattioli Engineering

Methods

  • Transdermal delivery of the cocktail through Dermoelectroporation® technology:
  • 2 Steps Prodecure:
    a)Microdermabrasion
    b) When targeting adipose tissue:
    Transdermal delivery of the cocktail through Ultrapeel®
    Transderm Meso® system. In this way:
    Delivered every 1-2 weeks until desired result is achieved.
    Prepare solution using (2) 10 cc syringes. Use one syringe per respective side. Areas are referred to as abdomen,
    thighs, etc.
    Per 10 cc syringe:
    4 cc Hyaluronidase 300 units/mL
    4 cc L-carnitine 500 mg/mL
    2 cc Phosphatidylcholine 100 mg/mL

Application of proper follow up at the end.

Results & Conclusions

  • Patients were treated with the following results: Patients drastically reduced inches in weeks.
  • Transdermal delivery is possible and safe with no contraindications reported.
  • All patients showed a good level of improvement and she was so happy with results.

Jaggy Rao, MD* , MD Division of Dermatology, University of Alberta Edmonton, Alberta, Canada

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal Hyaluronic Acid (HA) delivery using Dermelectroporation®

Study Design

  • 10 healthy female subjects
  • Symmetrical periorbital rhytids
  • Randomization: Only RIGHT or LEFT face treated
  • Efficacy Parameters:
    - Photography
    - Histology
    - Blinded dermatologist assessment
    - Subject questionnaires

 

Materials and Methods

Materials

  • Hyaluronic Acid 15 mg/ml, very low viscosity from Apothécure, Inc., Dallas, Texas
  • Ultrapeel® + TransDerm Ionto® from Mattioli Engineering, Florence, Italy

Methods

  • Side to be treated scrubbed with acetone
  • Periorbital region treated with microdermabrasion
  • 3.0 milliliters of HA transdermally delivered per Tx approximately 5 – 10 minutes per session (Picture 2)
  • Two transdermal treatments given, 2 weeks apart
  • Mupirocin ointment immediately post-treatment
  • 2 mm punch biopsies at 4 weeks post-treatment

Results

  • Minimal and transient side effects
    - erythema (10), mild abrasions (6), purpura (1)
  • All subjects tolerated the treatments well
    - average Tolerability Score = 2.2*
  • Subject questionnaires
    - average Improvement Score = 3.2**
    • 1 = no discomfort,
    • 2 = mild discomfort,
    • 3 = moderate discomfort,
    • 4 = severe discomfort
    ** 1 = no improvement, 2 = mild improvement, 3 = moderate improvement, and 4 = dramatic improvement
  • Average change in Wrinkle Class (1 – 5) *
    - Treated Side = - 1.3
    - Control Side = - 0.2
  • Pre- and 4-week follow-up photos evaluated by four independent blinded physician observers
    - Average improvement treated side = 3.3 **
    - Average improvement control side = 1.2 **
    * As determined by blinded dermatologist reviewer
    ** 1 = no improvement,
    2 = mild improvement,
    3 = moderate improvement,
    4 = dramatic improvement

Conclusions and Implications

  • Through Dermoelectroporation®, transdermal drug delivery of HA is possible and safe
  • This concept may improve the efficiency of other biological agents and drugs such as anesthetics, anti inflammatory, and photosensitizers
  • New studies are in progress to further examine the potential scope of this process

Dr. Suneil Jain, N.M.D.

Scottsdale Natural Medicine and Healing Clinic, LLC, 8390 E. Via de Ventura Blvd. Suite F-111 Scottsdale, AZ 85258

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of a fat reduction cocktail
on abdomen, lateral thigh, medial thigh & back through Dermoelectroporation®.

Study Design

  • Toning, not obesity grade treated
  • Treatments should be administered every 2 weeks.
    Average number of treatments 3-4.
  • L-Carnitine/Phosphatidylcholine cocktail was delivered
  • Ultrapeel® Transderm® Meso System
  • Session number depending on the single patient's condition
  • Study conclusion on 90% or more resolution of the affected sites

 

Materials and Methods

Materials

1. L-Carnitine - plays an important role in fat metabolism; shuttles long chain fatty acids across the mitochondrial membrane, once inside stimulates beta oxidation
2. Phosphatidylcholine - penetrates the adipose cell, acts as a fat emulsifier by altering the stored lipids making them water soluble
3. Ultrapeel® Transderm Meso® system from Mattioli Engineering

Methods

  • Transdermal delivery of the cocktail through Dermoelectroporation® technology:
  • 2 Steps Procedure:
    a)Microdermabrasion
    b) When targeting adipose tissue:
    Transdermal delivery of the cocktail through Ultrapeel® Transderm Meso® system. In this way:
    Delivered every 1-2 weeks until desired result is achieved .Prepare solution using (2) 10 cc syringes.
    Use one syringe per respective side. Per 10 cc
    syringe:
    4 cc L-carnitine 500 mg/mL
    6 cc Phosphatidylcholine 100 mg/mL.

Application of proper follow up at the end.

Results & Conclusions

  • Patients were treated with the following results: Patients drastically reduced inches in weeks.
  • Transdermal delivery is possible and safe with no contraindications reported.
  • All patients showed a good level of improvement and she was so happy with results.

Dr. James Fulton, vivant Skin Care , Miami Florida, USA

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of Oligopeptides serum for crow’s feet treatment purposes through Dermoelectroporation®.

Study Design

  • Delivered every week for a total of 4 treatments.
  • Oligopeptides (Vivant Skin Care) was delivered
  • Ultrapeel® Transderm® Ionto Meso System
  • Repeat ideally every week until desired result is achieved.

 

Materials and Methods

Materials

1. Oligopeptides serum
Reduces Lines & Generates New Collagen 2 Ultrapeel® Transderm Ionto Meso® system from Mattioli Engineering

Methods

  • Transdermal delivery of the cocktail through Dermoelectroporation® technology:
  • 2 Steps Procedure:
    a)Microdermabrasion
    b) Transdermal delivery of :
    Prepare solution using a 10cc syringe. Use one syringe concentrating on problematic areas like the cheeks and forehead at lateral brow line.
    Per 10cc syringe
    10cc Oligopeptides

Application of proper follow up at the end.

Results & Conclusions

  • Patients were treated with the following results: Patients drastically reduced inches in weeks.
  • Transdermal delivery is possible and safe with no contraindications reported.
  • All patients showed a good level of improvement and she was so happy with results.

Report on treating the crow’s feet area through Dermoelectroporation Pn. 55100150/E Mattioli Engineering All rights reserved

Dr. Gabriela Vasilescu, M.D. Vascular Surgery Specialist, PRIM Dept - Montedomini Clinic, via de Malcontenti, 6 – 50100, Florence, Italy

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of Specific substances for skin biorevitalization purposes through Dermoelectroporation®.

Study Design

  • 3 sessions in total.
  • 1 sitting every two/three weeks.
  • Specific substances delivered
  • Ultrapeel® Transderm® Meso System
  • Severe facial muscle relaxation treated

 

Materials and Methods

Materials

  • Substances: Cosmeceuticals (Omeopatia Italiana), Antioxidants(Amway Italia).
  • Ultrapeel® Transderm Meso® system from Mattioli Engineering
  • Eufoton 808 NM Diode Laser
  • Injector U225
  • Eulite Intense Pulse Light

Methods

Session 1:
1. 10W scanner 10/12 passes laser application
After 3 days:
2. 21J IPL application with Eulite IPL.
3. Ultrapeel® Transderm Meso® system for Vitamin C and Placentex® transdermal delivery
4. Mandelic chemical Peeling for purification

Home follow up on Session 1 :
1. Application of cosmeceuticals and Antioxidants(Amway Italia)

Session 2:
1. 10W scanner 12 passes laser application
2. 21J IPL application with Eulite IPL.
3. Ultrapeel® Transderm Meso® system for Vitamin C, Placentex® and Lymdiaral transdermal delivery
4. Mandelic chemical Peeling for purification
5. Vitamins, Aminoacids and OCTICATAL thru U225
mesotherapy gun

Home follow up on Session 2:
1. Application of cosmeceuticals and Antioxidants(Amway Italia)

Session 3:
1. 10W scanner 12 passes laser application
After 3 days :
2. ICG Laserpeel application
3. 21J IPL application with Eulite IPL.
4. Ultrapeel® Transderm Meso® system for Vitamin C, Placentex® and Lymdiaral transdermal delivery
5. Mandelic chemical Peeling for purification
6. Vitamins, Amino Acids, OCTICATAL and Polynucleotides
thru U225 mesotherapy gun
7. DMAE Mandelic chemical Peeling

Home follow up on Session 2:
Application of cosmeceuticals and Antioxidants(Amway Italia)

Results & Conclusions

  • 1 patient was treated with the following results: 1 patient cleared in 1 session.
  • The subject was very happy about results
  • Transdermal delivery is possible and safe with no contraindications

Dr. Gabriela Vasilescu, M.D.

Vascular Surgery Specialist, PRIM Dept - Montedomini Clinic, via de Malcontenti, 6 – 50100, Florence, Italy

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of Specific substances for skin acne treatment through Dermoelectroporation®.

Study Design

  • 5 sessions in total.
  • 1 sitting every two/three weeks.
  • Specific substances delivered
  • Ultrapeel® Transderm® Meso System
  • Severe skin acne treated

 

Materials and Methods

Materials

Substances: Vitamin C (Omeopatia Italiana), Placentex®, (Omeopatia Italiana) Antioxidants(Amway Italia), Lymdiaral (Pascoe Italiana)
•Ultrapeel® Transderm Meso® system from Mattioli Engineering
•Eufoton 808 NM Diode Laser
•Deka Mela Italy KTP 500nm Laser
•Eulite Intense Pulse Light

Methods

Session 1, 2 and 3:
1. Microdermabrasion with sterile crystals,
2. Purifying / Regenerative Mandelic chemical peeling (30%)
3. 9W Defocalized 3 J /CMQ Diode laser application
4. Sterilization of bacterial sites thru
5. 500 nm KTP laser to be alternated with ICG Laserpeel
7W 5J Defocalized at 2,3j every 9 Sqcm.
6. IPL Application with Eulite IPL.

Home follow up on Session 1 to 3:
1. Artistry Skin Balancing programme (Amway Italia)
2. Antioxidants (Amway Italia)
3. Booster clarifying treatment (Q-Med AB (publ))
4. Candida intestinal treatment

Session 4 and 5:
1. Microdermabrasion with sterile crystals,
2. 9W Defocalized 3 J /CMQ Diode laser application
3. Sterilization of bacterial sites thru
4. 500 nm KTP laser
5. Ultrapeel® Transderm Meso® system for Vitamin C, Placentex® and Lymdiaral transdermal delivery

Home follow up on Session 4 and 5:
1. Artistry Skin Balancing programme (Amway Italia)
2. Antioxidants(Amway Italia)
3. Booster clarifying treatment(Q-Med AB (publ)
4. Candida intestinal treatment

Results & Conclusions

  • 1 patient was treated with the following results: 1 patient cleared in 1 session.
  • The subject was very happy about results
  • Transdermal delivery is possible and safe with no contraindications

Dr. Suneil Jain, N.M.D.

Scottsdale Natural Medicine and Healing Clinic, LLC, 8390 E. Via de Ventura Blvd. Suite F-111 Scottsdale, AZ 85258

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of a Hyaluronic Acid cocktail on Perioribital & Perioral Areas through Dermoelectroporation®.

Study Design

  • Fine to medium lines of the face
  • Treatments should be administered every 2 weeks for 3 treatments. Thereafter every 6-8 weeks for maintenance.
  • L-Carnitine/Phosphatidylcholine cocktail was
    delivered
  • Ultrapeel® Transderm® Meso System
  • Session number depending on the single patient's condition
  • Study conclusion on 90% or more resolution

 

Materials and Methods

Materials

1. Hyaluronic Acid - plays an important role in tissue hydration, lubrication and cellular function; removes wastes from cells with no direct blood supply; able to hold more water than any other natural substance which results in smoothness, softening and decrease in wrinkles

2. Glutathione - “master antioxidant”; acts to reconstitute Vitamin C and E after they have been oxidized; protects cells from free radical damage; works in conjunction with Super Oxide Dismutase (enzymes that play a major role in the protection of cells from oxidative stress) to help with detoxification

3. MTE-4 – contains 4 multi-trace elements

a. Copper: important for conversion of Ltyrosine to melanin aiding in UV protections; needed for conversion of carotene to retinol; needed for CT maturation; provides cross-linking of aldehydes in collagen and elastin tissues; stimulates SOD enzyme

b. Manganese: activates enzymes in formation of collagen; tones & firms skin

c. Zinc Sulfate: required for synthesis of collagen; protects against UV rays; stimulates transport of Vitamin A from liver to skin; stimulates SOD enzyme d. Chromium: can help with acne by improving localized glucose sensitivity 4.Ultrapeel® Transderm Meso® system from Mattioli Engineering

Methods

  • Transdermal delivery of the cocktail through Dermoelectroporation® technology:
  • 2 Steps Procedure:
    a)Microdermabrasion
    b) When targeting adipose tissue:
    Transdermal delivery of the cocktail through Ultrapeel® Transderm Meso® system. In this way. Deliver every 2 weeks for 3 treatments. Thereafter every 6-8 weeks for maintenance. Prepare solution using a 10 cc syringe. After combining the ingredients transfer half of the solution to another 10 cc syringe. Use 1 syringe per side of the face.
    2 cc Sodium Hyaluronate 25 mg/mL
    2 cc Glutathione 100 mg/mL
    2 cc MTE 4 containing: (1 mg copper, 0.5 mg manganese, 10 mcg chromium, 22 mg zinc sulfate) per mL

Application of proper follow up at the end

Results & Conclusions

  • Patients were treated with the following results: Patients drastically reduced inches in weeks.
  • Transdermal delivery is possible and safe with no contraindications reported.
  • All patients showed a good level of improvement and she was so happy with results.

Dr. A.Gessati*,

*Aesthetic medicine Doctor, Milan, Italy.

 

Preliminary Study

Dermoelectroporation, well known and established method for transdermal substances delivery without the use of needles, promote the opening of membrane channels and allows the transdermal delivery of Hyaluronic acide based bio revitalizing and growth factor cocktails.
The LED stimulation provokes , due to a controlled , low intensity, ionizing light radiation, a biological response from the treated tissues. The procedure consists of a skin-compatible proteins transdermal delivery to improve the cellular cleaning and the restoration of microcirculation pathways in order to get a fast improvement on the external skin tissues.

Study Design

  • 10 patients were treated on 5 sessions - once per week.
  • Follow up after one month
  • Revitalase (Mattioli engineering -Italy)
  • Ultrapeel® Transderm® Meso System
  • 15mins application each session (AVG).
  • Treated areas : Per oral area.

 

Materials and Methods

Materials

  • Revitalase (Mattioli engineering)
  • Ultrapeel® Transderm® Meso System(Mattioli engineering)
  • L.E.D. Photo Stimulation device

Methods

  • Pre-Sterilised corundum crystals Microdermabrasion up to reach a strong
    hyperemia.
  • Transdermal delivery of 3cc Revitalase – (
  • Hyaluronic acid enriched by Tissue Growth Factors)cocktail
  • LED Photo-biomodulation 633+/-6 nm.
  • 1 session per week for a total of 5 sessions depending on the single patient.
  • Follow up after 1 month.

Results

  • Significant decreasing of the patient’s smoker’s lines on the selected areas.
  • Result Assessment : Good according to single
    patient’s satisfaction grade.

Conclusions

The present study proved the transdermal delivery of Revitalase through Ultrapeel® Transderm® Meso System is safe, possible and effective.
The administer therapy is:
- Easy to perform.
It doesn’t show up any problem either during or after the administration
It is well tolerated by the patient.
This methodology:
- non invasive.
- Pain Free.
- No side effect reported.

Report on smoker’s face lines treatment through Dermoelectroporation Pn. 55100120/E Mattioli Engineering All rights reserved

Dr. James Fulton, vivant Skin Care , Miami Florida, USA

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of a cellulitic serum for localized fat deposits reduction purposes through Dermoelectroporation®.

Study Design

  • Delivered every 1 weeks for a total of 8 treatments.
  • Cellulitic serum 5% (Vivant Skin Care) was delivered
  • Ultrapeel® Transderm® Ionto Meso System
  • Repeat ideally every week until desired results is achieved

 

Materials and Methods

Materials

  1. Cellulitic serum 5 Dissolves Localized Fatty deposits
  2. Ultrapeel® Transderm Ionto Meso® system from Mattioli Engineering

Methods

  • Transdermal delivery of the cocktail through Dermoelectroporation® technology:
  • 2 Steps Procedure:
    a)Microdermabrasion
    b) Transdermal delivery of:
    Prepare solution using (2) 10cc syringe. Use one syringe per area being treated, concentrating on problematic areas. Areas are referred to as abdomen, lateral thigh, medial thigh, back, arms, etc.
    Per 10cc syringe
    10cc Cellulolytic Serum

Application of proper follow up at the end.

Results & Conclusions

  • Patients were treated with the following results:
    Patients drastically reduced inches in weeks.
  • Transdermal delivery is possible and safe with no contraindications reported.
  • All patients showed a good level of improvement and she was so happy with results.

Report on Localized Fat Deposits treatment through Dermoelectroporation Pn. 55100220/E Mattioli Engineering All rights reserved

Dr. James Fulton, vivant Skin Care , Miami Florida, USA

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of Oligopeptides serum for crow’s feet treatment purposes through Dermoelectroporation®.

Study Design

  • Delivered every week for a total of 4 treatments.
  • Oligopeptides (Vivant Skin Care) was delivered
  • Ultrapeel® Transderm® Ionto Meso System
  • Repeat ideally every week until desired result is achieved.

 

Materials and Methods

Materials

  1. Oligopeptides serum
    Reduces Lines & Generates New Collagen
  2. Ultrapeel® Transderm Ionto Meso® system from Mattioli Engineering

Methods

  • Transdermal delivery of the cocktail through Dermoelectroporation® technology:
  • 2 Steps Procedure:
    a)Microdermabrasion
    b)Transdermal delivery of:
    Prepare solution using a 10cc syringe. Use one syringe concentrating on problematic areas like the cheeks and forehead at lateral brow line.
    Per 10cc syringe
    10cc Oligopeptides

Application of proper follow up at the end.

Results & Conclusions

  • Patients were treated with the following
    results: Patients drastically reduced inches in weeks.
  • Transdermal delivery is possible and safe with no contraindications reported.
  • All patients showed a good level of improvement and she was so happy with results.

Dr. Gabriela Vasilescu, M.D.

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of an Hydrating cocktail for skin aging treatment through Dermoelectroporation®.

Study Design

  • 5 sessions in total.
  • 1 sitting every three weeks.
  • Hydrating cocktail delivered
  • Ultrapeel® Transderm® Meso System
  • Severe skin aging treated

 

Materials and Methods

Materials

  • (VTF), Hyaluronic Acid, Vitamins, DMAE and antioxidants
  • Ultrapeel® Transderm Meso® system from Mattioli Engineering

Methods

  • Transdermal delivery of the Hydrating cocktail through Dermoelectroporation® technology:
  • 5 sessions in total:
    1st session Microdermabrasion and VTF only.
    2nd to 5th performed in two phases:
    Phase 1: Microdermabrasion (MDA) and transdermal delivery of Hydrating substances (VTF), Hyaluronic Acid, Vitamins, DMAE and antioxidants (in the third and fourth session, perform Citric mandelic peeling after MDS and then VTF).
    Phase 2: Diode Laser 808 nm, treatment with con 10/12W rotating scanner
    1 sitting every 3 weeks alternated with one sitting for skin stimulating every 10 days (laser & laserpeel with green coloration indocyanine; preliminary MDA and VTF); Total time to treatment 1 hour or so.

Application of proper SPF at the end.

Results & Conclusions

  • 1 patient was treated with the following results:
    1 patient cleared in 1 session.
  • The subject was very happy about results
  • Transdermal delivery is possible and safe with no contraindications reported.
  • The patient showed a good level of improvement and she was so happy with results.

 

Dr. A.Gessati*,
*Aesthetic medicine Doctor, Milan, Italy.

 

Preliminary Study

Dermoelectroporation, well known and established method for transdermal substances delivery without the use of needles, allows to get to important results for skin imperfection conditions, such as the inner arm areas relaxation (with the formation of bands of tissue in excess), which are often solved only through surgical methods. The correction of excessively relaxed skin, related to the loss of elastic features and support, requires biorevitalizing substances transdermal delivery(REVITALASE) commonly injected through a syringe, due to Ultrapeel Transderm Meso system device endorsing Dermoelectroporation technology. We developed an operating protocol Synergyzing the effect of biostimulanting substances driven through the skin with LED device(OMNILUX REVIVE 633 nm) able to to affect the cellular response.

Study Design

  • 5 patients were treated to follow-up every week.
  • Revitalase from Mattioli engineering -Italy)
  • Ultrapeel® Transderm® Meso System
  • Weekly Session (depending on the single patient's condition) for a total of 5 to 8 sessions.
  • 20mins application each session (AVG).
  • Treated areas: Hips, legs and abdomen.

 

Materials and Methods

Materials

  • Revitalase (Mattioli engineering)
  • Ultrapeel® Transderm® Meso System(Mattioli engineering)

Methods

  • Pre-Sterilised corundum crystals Microdermabrasion up to reach a strong hyperemia.
  • Transdermal delivery of REVITALASE – (Hyaluronic acid enriched by Tissue growth factors)
  • Red LED Photo-biomodulation 633+/-6 nm.
  • 1 session per week for a total of 5-8 sessions depending on the single patient.

Results

Significant decreasing of the patient’s cellulite sections and areas.
Result Assessment: Good according to single patient’s satisfaction grade.

Conclusions

The present study proved the transdermal delivery of Revitalase through Ultrapeel® Transderm® Meso System is safe, possible and effective.

The administer therapy is:

  • Easy to perform. It doesn’t show up any problem either during or after the administration. It is well tolerated by the patient.

 

This methodology:

  • Non invasive.
  • Pain Free.
  • No side effect reported.

Dr. James Fulton, vivant Skin Care , Miami Florida, USA

 

Preliminary Study

To evaluate the safety, tolerability and effectiveness of transdermal delivery of a Hyaluronic Acid & Oligopeptides cocktail
for either facial lifting and finelines reduction purposes through Dermoelectroporation®.

Study Design

  • Delivered every 1 or 2 weeks for a total of 8
    treatments.
  • Oligopeptides with Hyaluronic acid gel (Vivant Skin
    Care) was delivered
  • Ultrapeel® Transderm® Ionto Meso System
  • Repeat ideally every 12 week

 

Materials and Methods

Materials

  1. Oligopeptides serum 10% Reduces Lines & Generates New Collagen
  2. Hyaluronic acid serum 1% Fills out the Dermis and Hydrates the Joints
  3. Ultrapeel® Transderm Ionto Meso® system from Mattioli Engineering

Methods

  • Transdermal delivery of the cocktail through Dermoelectroporation® technology:
  • 2 Steps Prodecure:
    • a) Microdermabrasion
    • b) Transdermal delivery of:
      Prepare solution using a 10cc syringe. Use 5cc’s per side of the face, concentrating on problematic areas like the cheeks and forehead at lateral brow line.
      Per 10cc syringe
      5cc Oligopeptides
  • Application of proper follow up at the end.

Results & Conclusions

  • Patients were treated with the following results: Patients drastically reduced inches in weeks.
  • Transdermal delivery is possible and safe with no contraindications reported.
  • all patients showed a good level of improvement and she was so happy with results.

Report on Hyaluronic Acid and oligopeptides cocktail treatment through Dermoelectroporation Pn. 55100200/E Mattioli Engineering All rights

Dr. Gabriela Vasilescu, M.D.

Vascular Surgery Specialist, Martelli clinic, via del Bersaglio, 7 – Florence, Italy

 

Through Dermoelectroporation, the one and most innovative method for transdermal delivery of water based active ingredients into the body without needles, very important results have been achieved when fighting skin imperfections, elder and actinic keratosis normally cancelled using surgery.All our experiences in treating Actinic keratosis thru Dermoelectroporation have been carried out through the dose of a microdermabrader (till medium Hyperemia) and Transdermal delivery of skin regeneration ingredients (Placentex Mastelli), amino acids, Hyaluronic acid normally injected by syringes, driven through Transderm endorsing Dermoelectroporation. Technology.

Actinic Keratosis Protocol

  • Pre Sterilised crystals Microdermabrasion on the targeted area until a medium Hyperemia is reached
  • Transdermal delivery of 1 vial of Placentex not diluted, 2 cc of amino acids, 2 cc Hyaluronic Acid
  • 808 nm diode Laser for Photo Thermal lysis
  • 1 session every 15 days for a total of 4 sessions

Results & Conclusions

  • 1patient was treated with the following results:
    • 1 patient cleared in 1 session
    • The subject was very happy about results
    • Transdermal delivery is possible and safe with no contraindications reported
    • The patient showed a good level of improvement and she was so happy with results

Superficial radiation therapy (SRT) greatly reduces keloid recurrence rates and, for keratinocytic skin cancers, provides short-term cure rates similar to those in previous SRT research and of surgical options including Mohs surgery, Brian Berman, MD, PhD, told Dermatology Times®.Using ultrasound-based image guidance may improve nonmelanoma skin cancer (NMSC) out- comes, added Berman, Professor Emeritus of dermatology and cutaneous surgery at the University of Miami Miller School of Medicine and codirector of the Center for Clinical and Cos- metic Research in Aventura, both in Florida. Berman presented on SRT for keloid treatment as part of a conference track on dermatology updates for the therapy along with new and emerging medicines to treat skin cancers at the Music City Scale Symposium 16th Annual Meeting, August 18-22, 2021, in Nashville, Tennessee.1

VISUALIZING SKIN CANCERS

He pointed to a recent review of 2917 invasive and in situ keratinocytic carcinomas treated with image-guided SRT (IGSRT) which showed an overall control rate of 99.3% at patients’ last follow-up.2 Based on these results, authors led by Lio Yu, MD, suggested considering IGSRT as a first-line option for keratinocytic tumors in suitable early-stage patients. Yu is a radiation oncologist at Laserderm Dermatology in Smithtown, New York. “These results, while observed with approximately 55% of patients having follow-up for 12 months or more, appear at this time to be at least consistent with the results of standard surgical and nonsurgical modalities used to treat NMSC,” wrote the study authors.

Performing 22-MHz ultrasound imaging before SRT (SRT-100 Vision; Sensus Health- care) facilitates visualizing tumor depth up to 6 mm, said Berman, a consultant and investigator with Sensus. “Once you know the depth of the tumor, you can correlate it with percentage depth dose tables,” he said. Whereas the study’s 99.3% tumor control rate “at last follow-up” is a rather broad statement in his view, Berman said control rates were equally impressive when one considers only tumors with at least 1 year of follow-up (n = 1639, also 99.3%), and only invasive BCC and squamous cell carcinoma (n = 1242, 99.2%).

In fact, said Berman, the study’s 99% control rate is higher than the 90% to 96% rates reported in most SRT studies,3,4 and on par with results of Mohs surgery.5 “It’s not counterintuitive that if you can visualize the tumor, then you know where to aim the beam and how deep the beam needs to go,” he added. “[And] maybe you’re going to get a higher cure rate than what’s been in the literature, which has very robust data supporting the effectiveness of SRT on NMSC.”

“Having said that, I am not advocating using SRT for all nonmelanoma skin cancers in all patients,” he cautioned. “Surgery is the standard of care for nonmelanoma skin cancers.”

However, he said, SRT is well suited for patients who resist or cannot undergo surgery. In his experience practicing in Florida, Berman reported that patients who have undergone previous skin cancer excisions may reject additional scarring surgeries. Additionally, elderly patients with other comorbidities—Berman explained that, generally, relevant comorbidities increase with age—or those on anticoagulants may benefit by avoiding surgery, he noted.

David J. Goldberg, MD, JD, director of Skin Laser & Surgery Specialists; director of cos- metic dermatology and clinical research with the Schweiger Dermatology Group; clinical professor of dermatology and past director of Mohs surgery and laser research at Icahn School of Medicine at Mount Sinai, and adjunct professor of law at Fordham University School of Law, in New York, New York, also noted positive outcomes for this therapy. “Having an SRT unit added to my busy Mohs surgery office has greatly added to our ability to treat many more patients with nonmelanoma skin cancer,” he said. “Each technique has its benefits. With an increasingly older population of patients who are not good surgical candidates, SRT provides high cure rates for many people. Similarly, for a younger, cosmetically concerned patient base, SRT can lead to elegant cosmetic results with a high cure rate.”

The IGSRT study’s retrospective nature requires interpreting results cautiously, Berman said. However, he added, long-term prospective skin cancer studies are very difficult to perform. The 99% cure rate remains impressive, in his view. “If there’s a recurrence 3 years later, let’s say, in the margin where the port didn’t catch the original tumor, you’re not handcuffed from using surgery at that point,” he said.

TREATING KELOID RECURRENCE

Keloids commonly occur in high-visibility locations such as the face and earlobes. “When a patient comes to me with a keloid, I try to talk them out of surgery,” Berman said. Without adjunctive therapy such as SRT, recurrence rates are high, Berman added. In unpublished research, he reviewed 13 studies incorporating 343 patients and calculated a weighted-average postkeloidectomy recurrence rate of 71.2%.9,10“Very often, I’ll say, ‘You have a small keloid. If I were able to take away the burning, itching, and tenderness and get it softer and maybe a little flatter, would that be sufficient?’ And I hope they say yes, because there are other modalities to treat an existing keloid without cutting it out,” Berman said. With a referral-based practice, though, his patients typically want surgery because conservative treatments have failed.Berman explains to patients that postsurgical SRT offers a noninvasive tool for reducing recurrence risk. Separate studies show that this treatment reduces postsurgical recurrence rates to 3.0% and 10.4%, respectively.11,12 “Dropping the recurrence rate from 7 out of 10 to 1 out of 10, with at least 1 year of follow-up, is very helpful to the clinician to be able to hold out hope to patients,” he said.13

Radiation therapy is believed to treat keloid recurrence by reducing fibroblast proliferation, arresting the cell cycle, and inducing apoptosis.13 Although these mechanisms delay healing in normal skin, they are tailor-made for treating keloids with their excessive scarring and for destroying malignant, abnormal cells in nonmelanoma skin tumors arising from bro- blast or keratinocyte hyperproliferation, accord- ing to Berman.

“The mechanisms are consistent, but there are different reasons why we’d use it for keloids vs a tumor,” he said. The SRT-100 is FDA 510(k) cleared for treating NMSC and keloids. Berman said colleagues have told him that they bought the machine for NMSC but now use it more often for postsurgical keloid recurrences.Patients may worry about radiation therapy and carcinogenesis, Berman said. “I appreciate that. But I explain to them the historical safety of SRT, and the fact that it only goes a few milli- meters deep at most into the skin, [meaning] it’s truly super cial radiation therapy.”

Moreover, a 10-year retrospective analysis of 264 excised keloids, of which most received sub- sequent external-beam radiation or high dose- rate interstitial brachytherapy, showed no development of malignancy.14 Similarly, a search of Medline and PubMed between 1901 and March 2009 uncovered only 5 cases of carcinogenesis associated with, but not likely caused by, postkeloidectomy radiation therapy, Berman said. The cancers included BCC, thyroid cancer, breast cancer, and fibrosarcoma.

“Intuitively, it doesn’t make sense that radiation therapy induced the development of BCC because we use radiation therapy to treat BCC,” Berman said. Breast cancers originate at deeper levels than SRT penetrates, and the noted thyroid cancer did not develop in the treated area, he added. The single fibrosarcoma investigators found was probably a fibrosarcoma before surgery, authors allowed. These tumors typically take a decade to develop, Berman explained, whereas study follow-up periods generally are considerably shorter.

Pacemakers implanted in the treatment area are a contraindication for SRT, in his opinion. Regarding adverse effects, Berman said he warns patients about the potential for postradiation pigmentary changes, most often hyperpigmentation. In a chart review of 96 excised keloids followed for at least 1 year on which he was lead author, 56% of subjects experienced hyperpigmentation. Usually transient, he said, less than 5% of patients experienced persistent hyperpigmentation.

Because of the safety and efficacy of SRT, Berman suggested that more dermatologists con- sider o ering this therapy. “It’s part of our armamentarium to treat a patient who has disfiguring keloids that have an impact physically, cosmetically, and psychologically,” he said. In appropriately selected patients with keratinocytic skin cancers, results are commensurate with the standard of care, he added.

DisclosuresBerman is a consultant and investigator for Sensus. Goldberg reports no relevant nancial interests.

References1 Berman B. Super cial radiation therapy for keloids. Presented at: Music City SCALE Symposium for Cosmetic Advances and Laser Education 16th Annual Meeting; August 18-22, 2021; Nashville, Tennessee.2 Yu L, Oh C, Shea CR. The treatment of non-melanoma skin cancer with image- guided super cial radiation therapy: an analysis of 2917 invasive and in situ keratinocytic carcinoma lesions. Oncol Ther. 2021;9(1):153-166. doi:10.1007/ s40487-021-00138-43 Hernández-Machin B, Borrego L, Gil-García M, Hernández BH. Of ce-based radi- ation therapy for cutaneous carcinoma: evaluation of 710 treatments. Int J Der- matol. 2007;46(5):453-459. doi:10.1111/j.1365-4632.2006.03108.x4 Cognetta AB, Howard BM, Heaton HP, Stoddard ER, Hong HG, Green WH. Super- cial x-ray in the treatment of basal and squamous cell carcinomas: a via-
ble option in select patients. J Am Acad Dermatol. 2012;67(6):1235-1241. doi:10.1016/j.jaad.2012.06.0015 Tolkachjov SN, Brodland DG, Coldiron BM, et al. Understanding Mohs micro- graphic surgery: a review and practical guide for the nondermatologist. Mayo Clin Proc. 2017;92(8):1261-1271. doi:10.1016/j.mayocp.2017.04.0096 Rodriguez JM, Deutsch GP. The treatment of periocular basal cell carcinomas by radiotherapy. Br J Ophthalmol. 1992;76(4):195-197. doi:10.1136/bjo.76.4.1957  Grossi Marconi D, da Costa Resende B, Rauber E, et al. Head and neck non-mela- noma skin cancer treated by super cial x-ray therapy: an analysis of 1021 cases. PLoS One. 2016;11(7):e0156544. doi:10.1371/journal.pone.01565448  Lawrence WT. In search of the optimal treatment of keloids: report of a series and a review of the literature. Ann Plast Surg. 1991;27(2):164-178. doi:10.1097/00000637-199108000-000129  Shaffer JJ, Taylor SC, Cook-Bolden F. Keloidal scars: a review with a critical look at therapeutic options. J Am Acad Dermatol. 2002;46(2 Suppl Understand- ing):S63-S97. doi:10.1067/mjd.2002.12078810  Berman B, Nestor MS, Gold MH, Goldberg DJ, Fox J, Schmieder G. Low rate of keloid recurrences following treatment of keloidectomy sites with a biologically effective dose 30 of super cial radiation. SKIN The Journal of Cutaneous Medi- cine. 2018;2(6):402-403. doi:10.25251/skin.2.6.711  Berman B, Nestor MS, Gold MH, Goldberg DJ, Weiss ET, Raymond I. A retro- spective registry study evaluating the long-term ef cacy and safety of super - cial radiation therapy following excision of keloid scars. J Clin Aesthet Dermatol. 2020;13(10):12-16.12  Liu X, Liu JZ, Zhang E, et al. Impaired wound healing after local soft x-ray irra- diation in rat skin: time course study of pathology, proliferation, cell cycle, and apoptosis. J Trauma. 2005;59(3):682-690.13  Hoang D, Reznik R, Orgel M, Li Q, Mirhadi A, Kulber DA. Surgical excision and adjuvant brachytherapy vs external beam radiation for the effective treat- ment of keloids: 10-year institutional retrospective analysis. Aesthet Surg J. 2017;37(2):212-225. doi:10.1093/asj/sjw12414  Ogawa R, Yoshitatsu S, Yoshida K, Miyashita T. Is radiation therapy for keloids acceptable? The risk of radiation-induced carcinogenesis. Plast Reconstr Surg. 2009;124(4):1196-1201. doi:10.1097/PRS.0b013e3181b5a3ae

A new study on Superficial Radiation Therapy (SRT) shows that a single dose can be used to treat recurrence of keloid scarring after surgical excision. This study was conducted on fifteen patients with 20 untreated keloids in various anatomic locations. The results proved successful outcomes of 90%+ . The full study is attached.

Recently, a study was conducted on the efficacy of the treatment of keloid scarring using Superficial Radiation Therapy and was printed in the Journal of Clinical and Aesthetic Dermatology (JCAD) magazine. This study shows that when the surgical removal of keloids is followed by treatment with Superficial Radiation Therapy, the chances of the keloid scarring coming back are very minimal. To read the full study, please click here.

Michael E. Jones, MD,* Jennifer McLane, FNP,* Rachael Adenegan, FNP-C,* JoAnne Lee, PA-BC,*, and Christine A. Ganzer, PMHNP, PhD†

BACKGROUND/OBJECTIVE Management of keloids of the pinna, in particular, those located in the helix and antihelix and lobule that occur as complications of ear piercing.

MATERIALS AND METHODS Retrospective analysis of 49 patients treated with extralesional surgical excision of keloids localized to the ear followed by the application of autologous platelet-rich plasma (PRP) to wound site and postoperative in-office superficial radiation therapy (SRT). Radiation protocol consisted of 1 to 3 fractions, with a cumulative dosage ranging from 1,300 to 1,800 cGy. Average follow-up was 24 months to assess for evidence of recurrence and adverse side effects.

RESULTS Fifty ear keloids were treated with this method, age from 15 to 66 (mean = 32, SD = 16) of which 14 were male and 35 female. Almost 30% (n = 14) of patients acknowledged the source of injury that led to the development of the keloid was ear piercing. Treatment protocol achieved a 94% success rate with 3 patients who reported recurrence.

CONCLUSION Surgical excision combined with intraoperative PRP, adjuvant postoperative in-office SRT achieved a 94% nonrecurrence rate on follow-up over a 2-year period. Outcomes provide preliminary, albeit, strong evidence to support this multimodal method as a viable alternative in the management of keloids localized to the ear.

The authors have indicated no significant interest with commercial supporters.

Click here to view the full study.

Drexel University College of Medicine study suggests all organ transplant recipients should receive total-body screenings for skin cancer

Michael E. Jones; Cherrell Hardy, BSN, RN; and Julie Ridgway, BSN, RN

Jones Keloids Paper - July 2016 Advances in Skin & Wound Care

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