Microneedling Plus the Universal Peel For Acne Scarring

NCT02174393 | Completed

• 1 other identifier: E-14-555
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scarring

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

Microneedling Plus Universal Peel

EXPERIMENTAL

(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

Interventions

Universal Peel DRUG

Universal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol)

Microneedling Plus Universal Peel

Microneedling PROCEDURE

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

Microneedling Plus Universal Peel

Post-Microneedling Skin Care DRUG

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)

Microneedling Plus Universal Peel

Post-Universal Peel Skin Care DRUG

* 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

Microneedling Plus Universal Peel

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Englewood Hospital and Medical Center: lead
• Topix Pharmaceuticals: collaborator
• Eclipse Aesthetics: collaborator

Study Sites (1)

Bergen Dermatology

Englewood Cliffs, New Jersey, 07632, United States

Location

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Naana Boakye, MD

  Englewood Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 25, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

US (1)