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

NCT00654654 | Completed Phase 2 Results

• 1 other identifier: IT-R-007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (2)

• Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment

  Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.

  Baseline (prior to first treatment) compared to 6 months post last treatment

• Independent Panel Global Improvement Assessment Compared to Baseline

  An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.

  Baseline (prior to treatment) compared to 6 months post last treatment

Study Arms (1)

Active

EXPERIMENTAL

Biological: Autologous Human Fibroblasts (azficel-T)

Interventions

Autologous Human Fibroblasts (azficel-T) BIOLOGICAL

1. Collection of 3 mm biopsies 2. Two injection treatments of facial wrinkles and creases 3. Conduct of study assessments

Also known as: LAVIV

Active

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Castle Creek Biosciences, LLC.: lead

Study Sites (5)

Rhonda Rand, M.D., Inc.

Beverly Hills, California, 90210, United States

Location

The Laser Institute for Dermatology

Santa Monica, California, 90404, United States

Location

Winter Park and Orlando Plastic Surgery

Orlando, Florida, 32804, United States

Location

Dermatology Partners

Wellesley, Massachusetts, 02481, United States

Location

Dermatology, Laser and Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, 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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: March 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 13, 2012
• Results First Posted: March 13, 2012

Record last verified: 2012-02

Locations

US (5)