Microneedling Plus the Universal Peel For Acne Scarring

Acne Scarring Clinical Trial

Official title:

Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174393
• Other study ID #: E-14-555
• Status: Completed
• Phase: N/A
• First received: June 20, 2014
• Last updated: February 18, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Englewood Hospital and Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Scarring
• Cicatrix

Intervention

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

Procedure:
• Microneedling
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): 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)
• Post-Universal Peel Skin Care
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

Locations

Country	Name	City	State
United States	Bergen Dermatology	Englewood Cliffs	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Englewood Hospital and Medical Center	Eclipse Aesthetics, Topix Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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).	6 months	No
Secondary	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.	6 months	No
Secondary	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.	6 months	No