Efficacy & Safety of hADM Skin Booster
Summary
The goal of this randomized, split-face, double-blinded clinical trial is to evaluate the efficacy and safety of Elravie Re2O (particulated human Acellular Dermal Matrix, phADM) as a skin booster compared with hyaluronic acid (HA) skin booster alone in adults with skin roughness. The main questions it aims to answer are: 1. Does phADM combined with HA improve objective skin measurements and subjective skin assessments more effectively than HA alone? 2. Is phADM + HA treatment safe and well tolerated? Researchers will compare one half of participant's face treated with phADM + HA versus the opposite cheek treated with HA alone to see if phADM provides superior skin improvement. Participants will: 1. Be randomly assigned to receive three intradermal injections at one-month intervals, with phADM + HA on one cheek and HA alone on the other. 2. Undergo follow-up visits over 20 weeks for evaluation of ACSS score, instrumental skin quality measurements (e.g., skin density, volume, wrinkles), and satisfaction (GAIS). 3. Be monitored for local adverse events and changes in vital signs to assess safety.
Timeline
- Start
- 2024-11-21
- Primary completion
- 2025-05-07
- Completion
- 2025-05-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elravie Balance | Other / unclassified | 1.5 ml | Other |
| Subject | Elravie Balance | Other / unclassified | 20 mg/ml | Other |
| Subject | Elravie Re2O | Other / unclassified | 150 mg | Other |