A Pilot Study Testing the Efficacy of a Needling Device for the Treatment of Acne Scars

Study Overview
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Brief Summary
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The primary objective of this study is to determine the efficacy of a needling device for treatment of acne scars.

Detailed Description
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We are investigating a needled micro-roller for use in improving the appearance of acne scars. The study is being conducted under the direction of Dr. Murad Alam of Northwestern University, Department of Dermatology. The needles on the micro-roller are designed to create small holes in the top and mid layers of skin in order to induce the formation of more collagen, which would in turn help improve the appearance of acne scars. To qualify for the study, you must have at least 2 large areas of the face with acne scars. The study is designed such that one part of your face, which has acne scars, will be treated with the device on 3 separate occasions, spaced 2 weeks apart at our clinic in Chicago at Northwestern. We would also ask you to return at 3 months and at 6 months to have photographs taken. If you are interested in participating, we would like to get you involved as soon as possible

Official Title
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A Split-face Randomized Controlled Trial to Assess the Efficacy of a Needling Device for the Treatment of Acne Scars

Conditions
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Acne Scars

Intervention / Treatment
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* Procedure: needling treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-70 years old Subjects in general good health The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator Global Acne Scarring Classification grade 2-41 (Appendix II) Subject has at least two areas of acne scaring on the face (with at least 2 acne scars in each) that are at least 2 cm apart Exclusion Criteria: Pregnancy and lactation Subjects with history of keloid or hypertrophic scars Subjects with active skin disease (other than mild acne) or skin infection in the treatment area Subjects with an active systematic or local skin disease that is likely to alter wound healing Subjects who have undergone in the past 6 months or planning to undergo in the next 6 months the following cosmetic treatments in the acne scar area Injectable permanent filler Ablative laser treatment Subjects taking the following prescription medications: Accutane or other retinoids within the past 12 months Anticoagulant (warfarin) Subjects who allergic to lidocaine and prilocaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: needling treatment<br>Needling treatment applied to half of the face at each study visit | Procedure: needling treatment<br>* Needling treatment applied to half of the face at each study visit<br>|
| No Intervention: Control<br>No treatment applied to half of the face | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will evaluate qualitatively and quantitatively the improvement of the subject's acne scars |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The tolerability of the treatment will be assessed |  | 4 weeks | 
| Subject satisfaction will be determined |  | 6 months | 
| Any adverse events of this treatment will be recorded. |  | 6 months |