Collagen Injections for the Treatment of Acne Scars and Wrinkles

NCT01704209 | Terminated Phase 1 DMC

• 1 other identifier: STU67333
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scars; Wrinkles

Outcome Measures

Primary Outcomes (1)

• Change from baseline of rater's comparisons at 6 months

  Basline and 6 months

Study Arms (2)

Fibroblast Treatment

EXPERIMENTAL

The fibroblast treatment will be randomly injected into one side of the face.

Drug: Fibroblast Treatment

Vehicle

PLACEBO COMPARATOR

The vehicle will be injected randomly to the other side of the face.

Procedure: Vehicle

Interventions

Fibroblast Treatment DRUG

Fibroblast Treatment

Vehicle PROCEDURE

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 11, 2012
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 6, 2021

Record last verified: 2021-12

Locations

US (1)