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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00974870
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Tracking Information
First Submitted Date  ICMJE September 9, 2009
First Posted Date  ICMJE September 10, 2009
Last Update Posted Date December 2, 2021
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
We will evaluate qualitatively and quantitatively the improvement of the subject's acne scars [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • The tolerability of the treatment will be assessed [ Time Frame: 4 weeks ]
  • Subject satisfaction will be determined [ Time Frame: 6 months ]
  • Any adverse events of this treatment will be recorded. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study Testing the Efficacy of a Needling Device for the Treatment of Acne Scars
Official Title  ICMJE A Split-face Randomized Controlled Trial to Assess the Efficacy of a Needling Device for the Treatment of Acne Scars
Brief Summary The primary objective of this study is to determine the efficacy of a needling device for treatment of acne scars.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Scars
Intervention  ICMJE Procedure: needling treatment
Needling treatment applied to half of the face at each study visit
Study Arms  ICMJE
  • Experimental: needling treatment
    Needling treatment applied to half of the face at each study visit
    Intervention: Procedure: needling treatment
  • No Intervention: Control
    No treatment applied to half of the face
Publications * Alam M, Han S, Pongprutthipan M, Disphanurat W, Kakar R, Nodzenski M, Pace N, Kim N, Yoo S, Veledar E, Poon E, West DP. Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial. JAMA Dermatol. 2014 Aug;150(8):844-9. doi: 10.1001/jamadermatol.2013.8687.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2012)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2009)
30
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00974870
Other Study ID Numbers  ICMJE STU15904
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Murad Alam, Northwestern University
Original Responsible Party Murad Alam, Northwestern University
Current Study Sponsor  ICMJE Northwestern University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Murad Alam, MD Northwestern University
PRS Account Northwestern University
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP