Treatment of Acne Scarring With a Novel Procedure Combination
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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
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Sponsor:
Northwestern University
Information provided by (Responsible Party):
Murad Alam, Northwestern University
Tracking Information | ||||
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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 |
Scar Improvement [ Time Frame: 3.5 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 |
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Condition ICMJE | Acne Scarring | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |