Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases

NCT ID: NCT00654654

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-06-30

Brief Summary

The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases

Conditions

Facial Wrinkles and Creases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

Group Type: EXPERIMENTAL

Autologous Human Fibroblasts (azficel-T)

Intervention Type: BIOLOGICAL

1. Collection of 3 mm biopsies

2. Two injection treatments of facial wrinkles and creases

3. Conduct of study assessments

Interventions

Autologous Human Fibroblasts (azficel-T)

1. Collection of 3 mm biopsies

2. Two injection treatments of facial wrinkles and creases

3. Conduct of study assessments

Intervention Type: BIOLOGICAL

Other Intervention Names

LAVIV

Eligibility Criteria

Inclusion Criteria

• Male or female, at least 18 years of age
• High Investigator wrinkle severity assessment score
• Subject assessment of dissatisfaction of facial appearance
• Provide written informed consent and comply with the study requirements
• Negative pregnancy test at screening visit
• Healthy, non-scarred skin for biopsy

Exclusion Criteria

• Low Investigator wrinkle severity assessment score
• Subject assessment of satisfaction of facial appearance
• Physical attributes which prevent the assessment or treatment of the facial wrinkles
• Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial
• Previous treatment with Isolagen Therapy
• History of active autoimmune disease or organ transplantation
• Diagnosis of cancer, receiving active treatment
• History of pigmentary disorders which can affect the face
• Active or chronic skin disease
• Known genetic disorders affecting fibroblasts or collagen
• Active systemic infection
• Requires chronic antibiotic or steroidal therapy
• Use of certain cosmetic treatments & procedures
• Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
• Pregnant or lactating women or women trying to become pregnant
• Known allergic reaction to components of study treatment and/or study injection procedure
• Excessive exposure to sun or sunburn in the post-auricular area
• Subject has any disorder that may prevent compliance
• Subject who is part of the study staff, a family member or friend

• 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

Rhonda Rand, M.D., Inc.

Beverly Hills, California, United States

The Laser Institute for Dermatology

Santa Monica, California, United States

Winter Park and Orlando Plastic Surgery

Orlando, Florida, United States

Dermatology Partners

Wellesley, Massachusetts, United States

Dermatology, Laser and Vein Specialists of the Carolinas

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

IT-R-007

Identifier Type: -

Identifier Source: org_study_id