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

Phase 3

Completed

Interventions: Biological: Placebo
Biological: Autologous Human Fibroblast (azficel-T)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Active	Autologous Human Fibroblast (azficel-T)	-

Primary Outcome Measures

Name	Time	Method
Subject Wrinkle Assessment Responders	Baseline (prior to first treatment) and 6 months post final treatment	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.
Evaluator Wrinkle Severity Assessment Responders	Baseline (prior to first treatment) and 6 months after last treatment	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.

Secondary Outcome Measures

Name	Time	Method
Evaluator Wrinkle Severity Assessment Responders	Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment	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.
Subject Wrinkle Assessment Responders	Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment	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.

Locations (7): Silverburg Surgical & Medical Group
🇺🇸
Newport Beach, California, United States
Dermatology Research Institute, LLC
🇺🇸
Coral Gables, Florida, United States
Total Skin & Beauty Dermatology Center, PC
🇺🇸
Birmingham, Alabama, United States
River North Dermatology and Dermatologic Surgery
🇺🇸
Naperville, Illinois, United States
Dermatology, Laser & Vein Specialists of the Carolinas
🇺🇸
Charlotte, North Carolina, United States
Center for Skin Research
🇺🇸
Houston, Texas, United States
Aesthetic Solutions
🇺🇸
Chapel Hill, North Carolina, United States