Collagen Injections for the Treatment of Acne Scars and Wrinkles

December 2, 2021 updated by: Murad Alam, Northwestern University

Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fibroblast Treatment
The fibroblast treatment will be randomly injected into one side of the face.
Drug: Fibroblast Treatment
Placebo Comparator: Vehicle
The vehicle will be injected randomly to the other side of the face.
Procedure: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of rater's comparisons at 6 months
Time Frame: Basline and 6 months
Basline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU67333

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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