Microneedling Plus the Universal Peel For Acne Scarring
|ClinicalTrials.gov Identifier: NCT02174393|
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : February 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne Scarring||Drug: Universal Peel Procedure: Microneedling Drug: Post-Microneedling Skin Care Drug: Post-Universal Peel Skin Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Microneedling Plus Universal Peel
(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.
Drug: Universal Peel
Universal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol)
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
Drug: Post-Microneedling Skin Care
On Day 1 (after Microneedling procedure):
On Day 2-7:
On Day 7:
Drug: Post-Universal Peel Skin Care
- Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale. [ Time Frame: 6 months ]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. [ Time Frame: 6 Months ]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. [ Time Frame: 6 months ]The Global Assessment of Improvement will be completed at Week 17.
- Improvement in the appearance of acne scarring as subjectively measured through digital pictures. [ Time Frame: 6 months ]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. [ Time Frame: 6 months ]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. [ Time Frame: 6 months ]Subject will complete a pre-treatment questionnaire at Baseline and post-treatment questionnaires at Weeks 7 and 17.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174393
|United States, New Jersey|
|Englewood Cliffs, New Jersey, United States, 07632|
|Principal Investigator:||Naana Boakye, MD||Englewood Hospital and Medical Center|