Efficacy & Safety of hADM Skin Booster

NCT07155278 | Completed Phase 4

• 1 other identifier: 1-2024-0042
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 compared with hyaluronic acid (HA) skin booster alone in adults with skin roughness. The main questions it aims to answer are:

1. 1.Does phADM combined with HA improve objective skin measurements and subjective skin assessments more effectively than HA alone?
2. 2.Is phADM + HA treatment safe and well tolerated?
3. 3.Be randomly assigned to receive three intradermal injections at one-month intervals, with phADM + HA on one cheek and HA alone on the other.
4. 4.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).
5. 5.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

Keywords

Acellular dermal matrix; Dermal filler; Skin booster; Hyaluronic acid; Skin rejuvenation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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 Outcomes (1)

• Adverse event assessment

  From baseline to 20 weeks post-treatment

Study Arms (2)

Treatment arm A

EXPERIMENTAL

One randomly assigned half of each participant's face received a combination of Elravie Re2O (phADM) and Elravie Balance (hyaluronic acid).

Drug: Elravie Re2O; Drug: Elravie Balance

Treatment arm B

ACTIVE COMPARATOR

The remaining half of each participant's face received Elravie Balance (hyaluronic acid) only.

Drug: Elravie Balance

Interventions

Elravie Re2O DRUG

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.

Treatment arm A

Elravie Balance DRUG

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.

Treatment arm A; Treatment arm B

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• Korea International Cooperation Agency (KOICA): collaborator

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Study Officials

• Ju Hee Lee, M.D., Ph.D.

  Department of Dermatology & Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Each right or left side of the eligible participants' faces was randomly assigned one of the two treatment arms. The test side of each participant's face received a combination of Elravie Re2O (containing phADM) and Elravie Balance (Hyaluronic acid), while the control side received only Elravie Balance.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: November 21, 2024
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)