Treatment of Acne Scarring With a Novel Procedure Combination

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Murad Alam, Northwestern University

ClinicalTrials.gov Identifier:

NCT00510055

First received: July 31, 2007

Last updated: September 14, 2012

Last verified: September 2012

History of Changes

Purpose

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.

Condition	Intervention
Acne Scarring	Procedure: subdermal manipulation ONLY Procedure: subdermal manipulation AND injection of a filler


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance

Resource links provided by NLM:

MedlinePlus related topics: Acne Scars

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	30
Study Start Date:	June 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A scars receive subdermal manipulation ONLY	Procedure: subdermal manipulation ONLY scars receive subdermal manipulation ONLY Other Name: subcision
Experimental: B scars receive subdermal manipulation AND injection of a filler	Procedure: subdermal manipulation AND injection of a filler scars receive subdermal manipulation AND injection of a filler Other Name: Radiesse

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510055

Locations


United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators


Principal Investigator:	Murad Alam, MD	Northwestern University

More Information


Responsible Party:	Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier:	NCT00510055 History of Changes
Other Study ID Numbers:	STU752
Study First Received:	July 31, 2007
Last Updated:	September 14, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Cicatrix Fibrosis Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016

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