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

November 30, 2021 updated by: Murad Alam, Northwestern University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU15904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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