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

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

Study Overview

• Status: Completed
• Conditions: Facial Wrinkles and Creases
• Intervention / Treatment: Biological: Autologous Human Fibroblasts (azficel-T)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Rhonda Rand, M.D., Inc.
    • Santa Monica, California, United States, 90404
      • The Laser Institute for Dermatology
  • Florida
    • Orlando, Florida, United States, 32804
      • Winter Park and Orlando Plastic Surgery
  • Massachusetts
    • Wellesley, Massachusetts, United States, 02481
      • Dermatology Partners
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser and Vein Specialists of the Carolinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active	Biological: Autologous Human Fibroblasts (azficel-T); Collection of 3 mm biopsies; Two injection treatments of facial wrinkles and creases; Conduct of study assessments; Other Names: LAVIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Castle Creek Biosciences, LLC.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (Estimate): April 9, 2008

Study Record Updates

• Last Update Posted (Estimate): March 13, 2012
• Last Update Submitted That Met QC Criteria: February 9, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: IT-R-007