NCT02174393|Completed
Microneedling Plus the Universal Peel For Acne Scarring
Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI
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Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI
Sponsor study identifier
interventional
15
1 country
1
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 20, 2014
Actual (reported)June 25, 2014
Actual (reported)July 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 2015
Actual (reported)December 2015
Actual (reported)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).
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).
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.
6 months
Improvement in the appearance of acne scarring as subjectively measured through digital pictures.
6 months
Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.
6 months
Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.
6 months
(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.
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
Bergen Dermatology
Englewood Cliffs, New Jersey, 07632, United States
Naana Boakye, MD
Englewood Hospital and Medical Center
15 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2014
First Posted
June 25, 2014
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars
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
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Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
February 19, 2016
Record last verified: 2016-02
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