Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00649428 | Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles | PHASE3 | COMPLETED | 203 | — | — | Oct 1, 2006 | May 1, 2009 | Mar 13, 2012 | 7 | United States |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Control | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Autologous Human Fibroblast (azficel-T) | BIOLOGICAL | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face. |
| Placebo | BIOLOGICAL | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection visits administered 5 ± 1 weeks apart on each side of the face. |
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 * Negat...