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Treatment of Acne Scarring With a Novel Procedure Combination

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: NCT00510055
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Tracking Information
First Submitted Date  ICMJE July 31, 2007
First Posted Date  ICMJE August 1, 2007
Last Update Posted Date December 2, 2021
Study Start Date  ICMJE June 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2007)		 Scar Improvement [ Time Frame: 3.5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2007)		 Adverse Events [ Time Frame: 3.5 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 Treatment of Acne Scarring With a Novel Procedure Combination
Official Title  ICMJE The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance
Brief Summary The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance.
Detailed Description The primary objective of this study is to determine whether the use of subcision in conjunction with calcium hydroxylapatite injections will improve the appearance of rolling acne scars better than subcision alone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Scarring
Intervention  ICMJE
  • Procedure: subdermal manipulation ONLY
    scars receive subdermal manipulation ONLY
    Other Name: subcision
  • Procedure: subdermal manipulation AND injection of a filler
    scars receive subdermal manipulation AND injection of a filler
    Other Name: Radiesse
Study Arms  ICMJE
  • Experimental: A
    scars receive subdermal manipulation ONLY
    Intervention: Procedure: subdermal manipulation ONLY
  • Experimental: B
    scars receive subdermal manipulation AND injection of a filler
    Intervention: Procedure: subdermal manipulation AND injection of a filler
Publications * Not Provided

*   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)		 30
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2007)		 20
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 and over
  • Have two acne scar areas
  • The subjects are in 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.

Exclusion Criteria:

  • Under 18 years of age
  • Pregnancy or Lactation
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00510055
Other Study ID Numbers  ICMJE STU752
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 Not Provided
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