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Treatment of Acne Scarring With a Novel Procedure Combination

Primary Purpose

Acne Scarring

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
subdermal manipulation ONLY
subdermal manipulation AND injection of a filler
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scarring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

scars receive subdermal manipulation ONLY

scars receive subdermal manipulation AND injection of a filler

Outcomes

Primary Outcome Measures

Scar Improvement

Secondary Outcome Measures

Adverse Events

Full Information

First Posted
July 31, 2007
Last Updated
November 30, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00510055
Brief Title
Treatment of Acne Scarring With a Novel Procedure Combination
Official Title
The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scarring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
scars receive subdermal manipulation ONLY
Arm Title
B
Arm Type
Experimental
Arm Description
scars receive subdermal manipulation AND injection of a filler
Intervention Type
Procedure
Intervention Name(s)
subdermal manipulation ONLY
Other Intervention Name(s)
subcision
Intervention Description
scars receive subdermal manipulation ONLY
Intervention Type
Procedure
Intervention Name(s)
subdermal manipulation AND injection of a filler
Other Intervention Name(s)
Radiesse
Intervention Description
scars receive subdermal manipulation AND injection of a filler
Primary Outcome Measure Information:
Title
Scar Improvement
Time Frame
3.5 months
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
3.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Treatment of Acne Scarring With a Novel Procedure Combination

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