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Also known as Autologous Human Fibroblasts (azficel-T)
Autologous Human Fibroblasts · 4 trials · 4 indications
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.
Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.
Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.
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.
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.
A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.
A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Double blinded active | EXPERIMENTAL | Subject will receive autologous fibroblast treatment on either their left or right side of their face |
| Double blinded placebo | PLACEBO_COMPARATOR | Subject will receive placebo treatment on the opposite side of the face from active treatment |
| Name | Type | Description |
|---|---|---|
| Autologous Human Fibroblasts (azficel-T) | BIOLOGICAL | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three treatment visits with injections 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 treatment visits with injections 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...
Autologous Human Fibroblasts is being studied for dermatologic and oral soft tissue conditions, including acne scarring of the face, bilateral nasolabial fold wrinkles, facial wrinkles and creases, and interdental papillary insufficiency. It is an investigational cell-based therapy, not an approved product, and development is at Phase 2.
Autologous Human Fibroblasts targets ADA, which is classified as an exogenous gene target. The therapy uses a patient's own fibroblasts, the cells that produce collagen and other structural components of skin, to support tissue repair at the treatment site.
Autologous Human Fibroblasts is developed by Castle Biosciences, Inc., which trades under the ticker CSTL. The company is the sponsor associated with the clinical development program for this autologous fibroblast therapy across its dermatologic and oral soft tissue indications.
Autologous Human Fibroblasts is in Phase 2 development. It is investigational and has not been approved by the FDA. The program includes completed Phase 2 studies in acne scarring, facial wrinkles and creases, and interdental papillary insufficiency, plus a completed Phase 3 study in nasolabial fold wrinkles.
Completed trials include NCT00642642 in severe facial acne scarring, NCT00655356 in bilateral nasolabial fold wrinkles, NCT00654654 in facial wrinkles and creases, and NCT00655889 in interdental papillary insufficiency. All were conducted in the United States, and the studies were randomized, double blind, and placebo controlled.
Yes. Autologous Human Fibroblasts is also known as azficel-T. Both names refer to the same autologous fibroblast therapy developed by Castle Biosciences, Inc. for dermatologic conditions such as facial acne scarring, nasolabial fold wrinkles, and facial wrinkles and creases.