Treatment of Acne Scarring With a Novel Procedure Combination - Tabular View

Tracking Information

First Received Date ^ICMJE

July 31, 2007

Last Updated Date

September 9, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Scar Improvement [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Scar Improvement [ Time Frame: 3.5 months ]

Change History

Complete list of historical versions of study NCT00510055 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse Events [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Adverse Events [ Time Frame: 3.5 months ]

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Acne Scarring

Intervention ^ICMJE

Procedure: subdermal manipulation ONLY
Procedure: subdermal manipulation AND injection of a filler

Study Arms / Comparison Groups

Experimental: scars receive subdermal manipulation ONLY
Experimental: scars receive subdermal manipulation AND injection of a filler

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2009

Primary Completion Date

March 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00510055

Responsible Party

Murad Alam, MD, Northwestern University

Study ID Numbers ^ICMJE

STU00000752

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Murad Alam, MD

Northwestern University, Feinberg School of Medicine, Department of Dermatology

Information Provided By

Northwestern University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP