Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles

NCT00655356 | Completed Phase 3 Results

• 1 other identifier: IT-R-006
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.

Conditions

Bilateral Nasolabial Fold Wrinkles

Keywords

Treatment of moderate to severe bilateral nasolabial fold wrinkles

Outcome Measures

Primary Outcomes (2)

• Subject Wrinkle Assessment Responders

  A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.

  Baseline (prior to first treatment) and 6 months post final treatment

• Evaluator Wrinkle Severity Assessment Responders

  A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.

  Baseline (prior to first treatment) and 6 months after last treatment

Secondary Outcomes (2)

• Subject Wrinkle Assessment Responders

  Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment

• Evaluator Wrinkle Severity Assessment Responders

  Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment

Study Arms (2)

Active

EXPERIMENTAL

Biological: Autologous Human Fibroblasts (azficel-T)

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Autologous Human Fibroblasts (azficel-T) BIOLOGICAL

1. Collection of 3 mm post auricular skin punch biopsies. 2. Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.

Also known as: LAVIV

Active

Placebo BIOLOGICAL

1. Collection of 3 mm post auricular skin punch biopsies. 2. Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years of age
• Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol
• Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol
• Ability to comply with the study requirements
• Negative pregnancy test (Females)
• Healthy post-auricular skin for biopsy

You may not qualify if:

• Excessive dermatochalasis of the treatment area
• Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart
• Total area to be treated exceeds 20 cm in length
• Physical attributes which may prevent assessment or treatment as judged by the evaluator
• Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study
• Previous treatment with the sponsor's product
• History of active autoimmune disease or organ transplantation
• Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
• Active or chronic skin disease
• Known genetic disorders affecting fibroblasts or collagen
• Active systemic infection
• Requires chronic antibiotic or steroidal therapy
• Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
• Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
• Known allergic reactions to agents used in preparation of treatment

Sponsors & Collaborators

• Castle Creek Biosciences, LLC.: lead

Study Sites (6)

Brighton Medical Corporation

Beverly Hills, California, 91210, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Gwinnett Clinical Research Center

Snellville, Georgia, 30078, United States

Location

Dermatology San Antonio

San Antonio, Texas, 78229, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Institute of Anti Aging Research

Virginia Beach, Virginia, 23454, United States

Location

Results Point of Contact

• Title: Kevin Hennegan
• Organization: CBR International Corp.

khennegan@cbrintl.com

720-746-1190

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 9, 2008
• Study Start: November 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: May 1, 2009
• Last Updated: March 13, 2012
• Results First Posted: March 13, 2012

Record last verified: 2012-02

Locations

US (6)