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

Study Overview
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Brief Summary
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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.

Conditions
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Bilateral Nasolabial Fold Wrinkles

Intervention / Treatment
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* Biological: Autologous Human Fibroblast (azficel-T)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Biological: Autologous Human Fibroblast (azficel-T)<br>* Collection of 3 mm post auricular skin punch biopsies. Three injection treatments administered 5 ± 1 weeks apart on each side of the face.<br>* Other names: LAVIV;|
| Placebo Comparator: Control<br> | Biological: Placebo<br>* Collection of 3 mm post auricular skin punch biopsies. Three injection visits administered 5 ± 1 weeks apart on each side of the face.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of moderate to severe bilateral nasolabial fold wrinkles