Collagen Injections for the Treatment of Acne Scars and Wrinkles

Phase 1

Terminated

• Conditions: Acne Scars; Wrinkles
• Interventions: Procedure: Vehicle; Drug: Fibroblast Treatment

• Registration Number: NCT01704209
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-11
• Study Start: 2013-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	The vehicle will be injected randomly to the other side of the face.
Fibroblast Treatment	Fibroblast Treatment	The fibroblast treatment will be randomly injected into one side of the face.

Primary Outcome Measures

Name	Time	Method
Change from baseline of rater's comparisons at 6 months	Basline and 6 months

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States