Collagen Injections for the Treatment of Acne Scars and Wrinkles

Sponsor

Northwestern University (Other)

Overall Status

Terminated

CT.gov ID

NCT01704209

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Scars Wrinkles	Drug: Fibroblast Treatment Procedure: Vehicle	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fibroblast Treatment The fibroblast treatment will be randomly injected into one side of the face.	Drug: Fibroblast Treatment
Placebo Comparator: Vehicle The vehicle will be injected randomly to the other side of the face.	Procedure: Vehicle

Arm

Intervention/Treatment

Experimental: Fibroblast Treatment

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

Drug: Fibroblast Treatment

Placebo Comparator: Vehicle

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

Procedure: Vehicle

Outcome Measures

Primary Outcome Measures

Change from baseline of rater's comparisons at 6 months [Basline and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University

ClinicalTrials.gov Identifier:

NCT01704209

Other Study ID Numbers:

STU67333

First Posted:

Oct 11, 2012

Last Update Posted:

Dec 6, 2021

Last Verified:

Dec 1, 2021

Additional relevant MeSH terms:

Acne Vulgaris

Study Results

No Results Posted as of Dec 6, 2021