Microneedling Plus the Universal Peel For Acne Scarring

NCT ID: NCT02174393

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Universal Peel

Intervention Type: DRUG

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

Microneedling

Intervention Type: 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

Post-Microneedling Skin Care

Intervention Type: 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)

Post-Universal Peel Skin Care

Intervention Type: 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

Interventions

Universal Peel

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

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

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)

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Topix Pharmaceuticals

UNKNOWN

Sponsor Role: collaborator

Eclipse Aesthetics

UNKNOWN

Sponsor Role: collaborator

Englewood Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naana Boakye, MD

Role: PRINCIPAL_INVESTIGATOR

Englewood Hospital and Medical Center

Locations

Bergen Dermatology

Englewood Cliffs, New Jersey, United States

Countries

United States

Other Identifiers

E-14-555

Identifier Type: -

Identifier Source: org_study_id