Collagen Injections for the Treatment of Acne Scars and Wrinkles

Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01704209
• Other study ID #: STU67333
• Status: Terminated
• Phase: Phase 1
• Start date: April 2013
• Est. completion date: June 2013

Study information

• Verified date: December 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Scars
• Acne Vulgaris
• Wrinkles

Intervention

Drug:
• Fibroblast Treatment

Procedure:
• Vehicle

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of rater's comparisons at 6 months		Basline and 6 months