Microneedling Plus the Universal Peel For Acne Scarring

Not Applicable

Completed

• Conditions: Acne Scarring
• Interventions: Drug: Universal Peel; Procedure: Microneedling; Drug: Post-Microneedling Skin Care; Drug: Post-Universal Peel Skin Care

• Registration Number: NCT02174393
• Lead Sponsor: Englewood Hospital and Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Study Start: 2014-07
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microneedling Plus Universal Peel	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.
Microneedling Plus Universal Peel	Microneedling	(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.
Microneedling Plus Universal Peel	Post-Microneedling Skin Care	(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.
Microneedling Plus Universal Peel	Post-Universal Peel Skin Care	(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.

Primary Outcome Measures

Name	Time	Method
Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.	6 months	The scale will be completed at every office visit over the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Improvement in the appearance of acne scarring as measured by the 4 Point Scar Scale.	6 Months	The scale will be completed at each office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Improvement in the appearance of acne scarring as measured by the Global Assessment.	6 months	The Global Assessment of Improvement will be completed at Week 17.

Secondary Outcome Measures

Name	Time	Method
Improvement in the appearance of acne scarring as subjectively measured through digital pictures.	6 months	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).
Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.	6 months	The Cardiff Index will be completed at Baseline and Week 17.
Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.	6 months	Subject will complete a pre-treatment questionnaire at Baseline and post-treatment questionnaires at Weeks 7 and 17.

Trial Locations

Locations (1)

Bergen Dermatology; 🇺🇸 Englewood Cliffs, New Jersey, United States