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Collagen Injections for the Treatment of Acne Scars and Wrinkles

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Northwestern University

Status and phase

Terminated
Phase 1

Conditions

Wrinkles
Acne Scars

Treatments

Procedure: Vehicle
Drug: Fibroblast Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01704209
STU67333

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

4 participants in 2 patient groups, including a placebo group

Fibroblast Treatment
Experimental group
Description:
The fibroblast treatment will be randomly injected into one side of the face.
Treatment:
Drug: Fibroblast Treatment
Vehicle
Placebo Comparator group
Description:
The vehicle will be injected randomly to the other side of the face.
Treatment:
Procedure: Vehicle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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