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Collagen Injections for the Treatment of Acne Scars and Wrinkles

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ClinicalTrials.gov Identifier: NCT01704209
Recruitment Status : Terminated (Company stopped making product for cosmetic use. All consented subjects withdrew before any study interventions were performed.)
First Posted : October 11, 2012
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Acne Scars Wrinkles Drug: Fibroblast Treatment Procedure: Vehicle Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet
Study Start Date : April 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

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



Primary Outcome Measures :
  1. Change from baseline of rater's comparisons at 6 months [ Time Frame: Basline and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704209


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

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01704209     History of Changes
Other Study ID Numbers: STU67333
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014