Collagen Injections for the Treatment of Acne Scars and Wrinkles
NCT ID: NCT01704209
Last Updated: 2021-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2013-04-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Fibroblast Treatment
The fibroblast treatment will be randomly injected into one side of the face.
Fibroblast Treatment
Vehicle
The vehicle will be injected randomly to the other side of the face.
Vehicle
Interventions
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Fibroblast Treatment
Vehicle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU67333
Identifier Type: -
Identifier Source: org_study_id