Effect of Subcision and Suction on Acne Scars

• ClinicalTrials.gov Identifier: NCT01696513
• Recruitment Status: Active, not recruiting
• First Posted: October 1, 2012
• Last Update Posted: October 2, 2018
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Murad Alam, Northwestern University

Tracking Information

• First Submitted Date: September 14, 2012
• First Posted Date: October 1, 2012
• Last Update Posted Date: October 2, 2018
• Study Start Date: September 2012
• Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 27, 2012)

Change in acne scarring compared to baseline after treatments [ Time Frame: Baseline and 4 months ]

The change in acne scarring is measured using a global scarring grading system to compare baseline scarring to the treatments.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01696513 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Subcision and Suction on Acne Scars
• Official Title: Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Subcision and Suctioning With a Microdermabrasion Device on Rolling Acne Scars
• Brief Summary: The primary objective of this study is to determine whether the use of standard treatment in conjunction with suction will improve acne scars compared to a standard treatment alone.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Scars

Intervention

• Procedure: Suction
• Procedure: Subcision

Study Arms

• Experimental: Subcision & Suction
  Standard treatment for acne scars followed by suction.
  Interventions:

  • Procedure: Suction
  • Procedure: Subcision
• Active Comparator: Subcision
  Standard treatment for acne scars only
  Intervention: Procedure: Subcision

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 27, 2012): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2019
• Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age 18 and over
• Have bilateral rolling acne scars
• Are in good health
• Subject has the willingness and ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

• Under 18 years of age
• Pregnancy or lactation
• Unable to understand the protocol or give informed consent
• Has mental illness
• Recent Accutane use in the past 6 months
• Prone to hypertrophic and keloidal scarring

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 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: NCT01696513
• Other Study ID Numbers: STU66710
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Murad Alam, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Murad Alam, MD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: October 2018