Microneedling Plus the Universal Peel For Acne Scarring
Primary Purpose
Acne Scarring
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Universal Peel
Microneedling
Post-Microneedling Skin Care
Post-Universal Peel Skin Care
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scarring
Eligibility Criteria
Inclusion Criteria:
- Subject > 18 and < 60 years of age.
- Subject has skin type III, IV, V, or VI as defined by the Fitzpatrick Classification Scale.
- Subject has acne scarring as defined by the Goodman and Baron Grading System.
Exclusion Criteria:
- Subject currently has moderate to severe acne on the face.
- Subject has an active infection.
- Subject is pregnant or lactating.
- Subject has a history of a bleeding disorder.
- Subject is taking an anti-coagulant.
- Subject has a history of keloidal tendency.
- Subject has received ablative or non-ablative laser treatments in the previous 6 months.
- Subject has taken Accutane within the previous 3 months.
Sites / Locations
- Bergen Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microneedling Plus Universal Peel
Arm Description
(1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each. Microneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11.
Outcomes
Primary Outcome Measures
Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.
The scale will be completed at every office visit over the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Improvement in the appearance of acne scarring as measured by the 4 Point Scar Scale.
The scale will be completed at each office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Improvement in the appearance of acne scarring as measured by the Global Assessment.
The Global Assessment of Improvement will be completed at Week 17.
Secondary Outcome Measures
Improvement in the appearance of acne scarring as subjectively measured through digital pictures.
Pictures of the subject will be taken by the Principal Investigator at every office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.
The Cardiff Index will be completed at Baseline and Week 17.
Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.
Subject will complete a pre-treatment questionnaire at Baseline and post-treatment questionnaires at Weeks 7 and 17.
Full Information
NCT ID
NCT02174393
First Posted
June 20, 2014
Last Updated
February 18, 2016
Sponsor
Englewood Hospital and Medical Center
Collaborators
Topix Pharmaceuticals, Eclipse Aesthetics
1. Study Identification
Unique Protocol Identification Number
NCT02174393
Brief Title
Microneedling Plus the Universal Peel For Acne Scarring
Official Title
Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Englewood Hospital and Medical Center
Collaborators
Topix Pharmaceuticals, Eclipse Aesthetics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults. Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions, and depending on the skin type, significant erythema (redness) or post-inflammatory hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the aforementioned types of lesions. Pharmacologic management is essential, but safe procedural therapies are also necessary specifically with darker skinned individuals.
Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using a micro-needling device, which is safe and effective in causing "micro-wounds" into the dermis thereby initiating wound healing followed by collagen production. This is an ideal treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin types . Currently there are very few studies evaluating the safety and efficacy of microneedling and chemical peels in skin types III-VI.
The aim of this study is to evaluate the effects of the combination of microneedling and chemical peel for the treatment of acne scars in skin types III-VI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scarring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microneedling Plus Universal Peel
Arm Type
Experimental
Arm Description
(1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each.
Microneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11.
Intervention Type
Drug
Intervention Name(s)
Universal Peel
Intervention Description
Universal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol)
Intervention Type
Procedure
Intervention Name(s)
Microneedling
Intervention Description
Microneedling: is a device for all skin types that creates micro "injuries" in the dermis (layer of the skin underneath the outermost layer) in an attempt to trigger new collagen (natural component of skin tissue) production for smoother, firmer and younger-looking skin.
For this protocol, the needle depth will be increased over the 3 sessions:
Forehead: 0.75 mm, 0.85 mm, 1.0 mm. Cheeks/Chin: 1.0 mm, 1.5 mm, 2.0 mm.
Each Session: Microneedling procedure on Day 1, followed by skin care regimen
Intervention Type
Drug
Intervention Name(s)
Post-Microneedling Skin Care
Intervention Description
On Day 1 (after Microneedling procedure):
Gentle Antioxidant Soothing Cleanser daily
Soothing Recovery Ointment and Sheer Physical Sunscreen
On Day 2-7:
AM: Physical sheer sunscreen and recovery ointment
PM: Retinol/Vitamin C in the evening and soothing recovery ointment
On Day 7:
AM: BD Hydrating Day/Night Cream
PM: Retinol and Vitamin C and the BD Hydrating Day/Night Cream (if necessary)
Intervention Type
Drug
Intervention Name(s)
Post-Universal Peel Skin Care
Intervention Description
Gentle Antioxidant Soothing Cleanser daily
Physical Sunscreen daily
Soothing recovery ointment fortified with silver only when peeling occurs
After completely peeling, vitamin c product in the morning and the retinol in the evening
Primary Outcome Measure Information:
Title
Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.
Description
The scale will be completed at every office visit over the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Time Frame
6 months
Title
Improvement in the appearance of acne scarring as measured by the 4 Point Scar Scale.
Description
The scale will be completed at each office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Time Frame
6 Months
Title
Improvement in the appearance of acne scarring as measured by the Global Assessment.
Description
The Global Assessment of Improvement will be completed at Week 17.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in the appearance of acne scarring as subjectively measured through digital pictures.
Description
Pictures of the subject will be taken by the Principal Investigator at every office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Time Frame
6 months
Title
Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.
Description
The Cardiff Index will be completed at Baseline and Week 17.
Time Frame
6 months
Title
Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.
Description
Subject will complete a pre-treatment questionnaire at Baseline and post-treatment questionnaires at Weeks 7 and 17.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject > 18 and < 60 years of age.
Subject has skin type III, IV, V, or VI as defined by the Fitzpatrick Classification Scale.
Subject has acne scarring as defined by the Goodman and Baron Grading System.
Exclusion Criteria:
Subject currently has moderate to severe acne on the face.
Subject has an active infection.
Subject is pregnant or lactating.
Subject has a history of a bleeding disorder.
Subject is taking an anti-coagulant.
Subject has a history of keloidal tendency.
Subject has received ablative or non-ablative laser treatments in the previous 6 months.
Subject has taken Accutane within the previous 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naana Boakye, MD
Organizational Affiliation
Englewood Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bergen Dermatology
City
Englewood Cliffs
State/Province
New Jersey
ZIP/Postal Code
07632
Country
United States
12. IPD Sharing Statement
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Microneedling Plus the Universal Peel For Acne Scarring
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