Treatment of Acne Scarring With a Novel Procedure Combination

Tracking Information
First Submitted Date ICMJE	July 31, 2007
First Posted Date ICMJE	August 1, 2007
Last Update Posted Date	September 17, 2012
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	Complete list of historical versions of study NCT00510055 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Murad Alam, Northwestern University
Study Sponsor ICMJE	Northwestern University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Murad Alam, MD Northwestern University
PRS Account	Northwestern University
Verification Date	September 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP