NCT01704209TerminatedPhase 1
Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Northwestern University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Change from baseline of rater's comparisons at 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Fibroblast Treatment
Experimental
The fibroblast treatment will be randomly injected into one side of the face.
Intervention: Fibroblast Treatment (Drug)
Vehicle
Placebo Comparator
The vehicle will be injected randomly to the other side of the face.
Intervention: Vehicle (Procedure)
Outcomes
Primary Outcomes
Change from baseline of rater's comparisons at 6 months
Time Frame: Basline and 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation
Northwestern University
Study Sites (1)
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