Status:
COMPLETED
Efficacy & Safety of hADM Skin Booster
Lead Sponsor:
Yonsei University
Collaborating Sponsors:
Korea International Cooperation Agency (KOICA)
Conditions:
Rhytides
Skin Texture Irregularities
Eligibility:
All Genders
30-65 years
Phase:
PHASE4
Brief 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 comp...
Eligibility Criteria
Inclusion
- Male or female aged 30 to 65 years old
- Those with an Allergan Cheek Smoothness Scale (ACSS) score of 2-3 during screening
Exclusion
- Those who have received dermal fillers, botulinum toxin injections, mesotherapy, or other cosmetic procedures (e.g., laser) on the face within 12 months of screening or plan to receive such treatments during the trial period.
- Those who received facial wrinkle correction treatment within 6 months of screening
- Those with inflammatory diseases in the facial area
- Those with infectious diseases, skin grafts, keloids, or hypertrophic scars on the face.
- Those with autoimmune diseases
- Those who have experienced anaphylaxis or severe complex allergies for any reason
- Those who were prescribed anticoagulant therapy within 2 weeks of the screening date
- Those with a history of serious cardiopulmonary disease
- Breastfeeding
- Those who have started using or taking external or oral agents for wrinkle improvement within 30 days of screening
Key Trial Info
Start Date :
November 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07155278
Start Date
November 21 2024
End Date
May 7 2025
Last Update
September 4 2025
Active Locations (1)
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1
Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722