NCT07155278

Efficacy & Safety of hADM Skin Booster

Efficacy and Safety of a Particulated Human Acellular Dermal Matrix Skin Booster: A Randomized, Split-Face, Double-blinded, Prospective Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhytides
• Skin Texture Irregularities
• Photoaged Facial Skin
• Skin Lifting and Tightening

Interventions

Type	Name	Description
DRUG	Elravie Re2O	Elravie Re2O is a particulated human Acellular Dermal Matrix (phADM), with each 5 mL syringe containing 150 mg of phADM. This product is classified as a human tissue product and received its approval via a tissue bank establishment permit from the Ministry of Food and Drug Safety.
DRUG	Elravie Balance	Elravie Balance is a gel-type hyaluronic acid (HA) skin booster. It contains HA at a concentration of 20mg/ml in a 2.5 cc syringe with a volume of 1.5 mL.

Timeline

• Start date: 2024-11-21
• Primary completion: 2025-05-07
• Completion: 2025-05-07
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: South Korea