Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NOA HYDRATION · 1 trial · 1 indication
Responder is defined as a participant with at least 1-point improvement (reduction) from Baseline on the ACSS on both cheeks. The ACSS is a validated 5-point scale developed to grade the severity of skin smoothness on the cheeks. The scale ranges from 0 (None: smooth skin) to 4 (Extreme: very rough skin with pronounced crevices). Higher scores indicate worse skin smoothness.
A responder is defined as a participant with improvement in the GAIS. The GAIS is used by the EI to assess global aesthetic improvement of the face.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Treatment Group | EXPERIMENTAL | Participants receive initial treatment with NOA HYDRATION injection at Day 1 (Baseline) and optional touch-up treatment at Day 30. |
| Control Group | OTHER | Participants are followed for 2 months after randomization in a no-treatment control period and then either exit the study or receive optional treatment. |
| Name | Type | Description |
|---|---|---|
| NOA HYDRATION | DEVICE | Injection |
Inclusion Criteria: * Seeking improvement of skin quality including attributes such as skin smoothness * Has a symmetric ACSS score of Moderate (2) or Severe (3) on both cheeks * FACE-Q Satisfaction with Skin Questionnaire sum of raw scores \<= 39 and scores of "Very Dissatisfied" or "Somewhat Diss...