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Collagen Injections for the Treatment of Acne Scars and Wrinkles

Primary Purpose

Acne Scars, Wrinkles

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fibroblast Treatment
Vehicle
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 or over
  • Bilateral acne scars or have moderate to severe wrinkles
  • Subjects in good health
  • Subjects 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
  • recent Accutane use in the past 6 months
  • prone to hypertrophic and keloidal scarring
  • have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total
  • have a history of autoimmune disorders, organ transplantation, cancer not in remission, active or chronic skin disease
  • have a history of basal-cell carcinoma
  • have previously received autologous fibroblast treatment
  • have undergone any confounding therapy in the lower two-thirds of the face within 1 year or any investigational treatment within 30 days.
  • have an allergy to collagen, bovine products, local anesthetics, gentamicin, or amphotericin B
  • 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

Placebo Comparator

Arm Label

Fibroblast Treatment

Vehicle

Arm Description

The fibroblast treatment will be randomly injected into one side of the face.

The vehicle will be injected randomly to the other side of the face.

Outcomes

Primary Outcome Measures

Change from baseline of rater's comparisons at 6 months

Secondary Outcome Measures

Full Information

First Posted
September 27, 2012
Last Updated
December 2, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01704209
Brief Title
Collagen Injections for the Treatment of Acne Scars and Wrinkles
Official Title
Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Company stopped making product for cosmetic use. All consented subjects withdrew before any study interventions were performed.
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to find out if autologous (your own) fibroblast injections are effective for the treatment of acne scars and wrinkles.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibroblast Treatment
Arm Type
Experimental
Arm Description
The fibroblast treatment will be randomly injected into one side of the face.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
The vehicle will be injected randomly to the other side of the face.
Intervention Type
Drug
Intervention Name(s)
Fibroblast Treatment
Intervention Type
Procedure
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
Title
Change from baseline of rater's comparisons at 6 months
Time Frame
Basline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 or over Bilateral acne scars or have moderate to severe wrinkles Subjects in good health Subjects 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 recent Accutane use in the past 6 months prone to hypertrophic and keloidal scarring have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total have a history of autoimmune disorders, organ transplantation, cancer not in remission, active or chronic skin disease have a history of basal-cell carcinoma have previously received autologous fibroblast treatment have undergone any confounding therapy in the lower two-thirds of the face within 1 year or any investigational treatment within 30 days. have an allergy to collagen, bovine products, local anesthetics, gentamicin, or amphotericin B 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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Collagen Injections for the Treatment of Acne Scars and Wrinkles

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