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

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.

Study Overview

• Status: Completed
• Conditions: Rhytides; Photoaged Facial Skin; Skin Lifting and Tightening; Skin Texture Irregularities
• Intervention / Treatment: Drug: Elravie Re2O; Drug: Elravie Balance

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03722
    • Severance hospital, Yonsei university college of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female aged 30 to 65 years old
• Those with an Allergan Cheek Smoothness Scale (ACSS) score of 2-3 during screening

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm A; One randomly assigned half of each participant's face received a combination of Elravie Re2O (phADM) and Elravie Balance (hyaluronic acid).	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.
Active Comparator: Treatment arm B; The remaining half of each participant's face received Elravie Balance (hyaluronic acid) only.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasolabial fold depth	Nasolabial fold depth was measured using the Antera 3D CS (Miravex, Dublin, Ireland), which quantifies wrinkle depth in millimeters (mm)	Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Under-eye wrinkles	The Eve V (EVELAB INSIGHT, Singapore) was used to measure under-eye wrinkles in pixels.	Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Skin volume	Skin volume was measured in cubic millimeters (mm3) with the 3D LifeViz micro (QuantifiCare, Biot, France)	Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Skin density	Skin density was evaluated in percentage (%) using the Skin Scanner (tpm, Luneburg, Germany)	Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Pore area	Pore area was measured using the Antera 3D CS (Miravex, Dublin, Ireland), which quantifies pore area in millimeters squared (mm2).	Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Eye and cheek area lifting	Eye and cheek area lifting was assessed with the Morpheus3D (Morpheus, Gyeonggi, Republic of Korea),which measures the increase in curve length in millimeters to determine the degree of lifting.	Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Global Aesthetic Improvement Scale	Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Allergan Cheek Smoothness Scale	Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event assessment	The safety of the test products was assessed throughout the study period. During each visit, participants were monitored for any adverse reactions, and the use of any concomitant medications that could potentially affect the study was checked. All confirmed and reported adverse reactions from all subjects were compiled to determine the incidence rate, which was then used as data for the overall safety evaluation of the product.	From baseline to 20 weeks post-treatment

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Korea International Cooperation Agency (KOICA)
• Investigators: Principal Investigator: Ju Hee Lee, M.D., Ph.D., Department of Dermatology & Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Actual): May 7, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: August 26, 2025
• First Submitted That Met QC Criteria: August 26, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hyaluronic acid; Skin rejuvenation; Acellular dermal matrix; Dermal filler; Skin booster
• Other Study ID Numbers: 1-2024-0042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies that restrict data sharing beyond the research team. Data were collected under a protocol that did not include participant consent for public or external data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No