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

• ClinicalTrials.gov Identifier: NCT00974870
• Recruitment Status: Completed
• First Posted: September 10, 2009
• Last Update Posted: December 2, 2021
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Murad Alam, Northwestern University

Tracking Information

• First Submitted Date: September 9, 2009
• First Posted Date: September 10, 2009
• Last Update Posted Date: December 2, 2021
• Study Start Date: November 2009
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Pilot Study Testing the Efficacy of a Needling Device for the Treatment of Acne Scars
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acne Scars

Intervention

Procedure: needling treatment

Needling treatment applied to half of the face at each study visit

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 14, 2012): 20
• Original Estimated Enrollment (submitted: September 9, 2009): 30
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00974870
• Other Study ID Numbers: STU15904
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Murad Alam, Northwestern University
• Original Responsible Party: Murad Alam, Northwestern University
• Current Study Sponsor: Northwestern University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Murad Alam, MD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: November 2021