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

NCT ID: NCT00655356

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active

Group Type: EXPERIMENTAL

Autologous Human Fibroblasts (azficel-T)

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Autologous Human Fibroblasts (azficel-T)

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.

Intervention Type: BIOLOGICAL

Placebo

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

LAVIV

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Excessive exposure to sun without adequate sun protection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Castle Creek Biosciences, LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brighton Medical Corporation

Beverly Hills, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Gwinnett Clinical Research Center

Snellville, Georgia, United States

Dermatology San Antonio

San Antonio, Texas, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Institute of Anti Aging Research

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

IT-R-006

Identifier Type: -

Identifier Source: org_study_id