An interventional study of Universal Peel and Microneedling in Acne Scarring, sponsored by Englewood Hospital and Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by Englewood Hospital and Medical Center · Not applicable, Interventional, and Treatment
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.
307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's enrollment of 15 is below the median of 39 across 251 interventional studies indexed under Cicatrix.
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Exclusion Criteria:
(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 · Procedure: Microneedling · Drug: Post-Microneedling Skin Care · Drug: Post-Universal Peel Skin Care
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
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)
* 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
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).
Time frame: 6 months
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).
Time frame: 6 Months
Improvement in the appearance of acne scarring as measured by the Global Assessment.
The Global Assessment of Improvement will be completed at Week 17.
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Englewood Hospital and Medical Center