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

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.

Study Overview

• Status: Completed
• Conditions: Bilateral Nasolabial Fold Wrinkles
• Intervention / Treatment: Biological: Autologous Human Fibroblasts (azficel-T); Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 91210
      • Brighton Medical Corporation
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Dermatology San Antonio
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Virginia Beach, Virginia, United States, 23454
      • Institute of Anti Aging Research

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Collection of 3 mm post auricular skin punch biopsies.; Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.
Experimental: Active	Biological: Autologous Human Fibroblasts (azficel-T); Collection of 3 mm post auricular skin punch biopsies.; Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.; Other Names: LAVIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) compared to 3rd treatment visit, 2 and 4 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) compared to 3rd treatment visit, 2 and 4 months post final treatment

Collaborators and Investigators

• Sponsor: Castle Creek Biosciences, LLC.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 31, 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

• Keywords: Treatment of moderate to severe bilateral nasolabial fold wrinkles
• Other Study ID Numbers: IT-R-006