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OpenTrials
Completed

NCT Number: NCT07155278

Efficacy & Safety of hADM Skin Booster

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.

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Key information

Conditions

Rhytides Photoaged Facial Skin Skin Lifting and Tightening Skin Texture Irregularities

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Nasolabial fold depth

    Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

    Nasolabial fold depth was measured using the Antera 3D CS (Miravex, Dublin, Ireland), which quantifies wrinkle depth in millimeters (mm)

  2. Under-eye wrinkles

    Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

    The Eve V (EVELAB INSIGHT, Singapore) was used to measure under-eye wrinkles in pixels.

  3. Skin volume

    Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

    Skin volume was measured in cubic millimeters (mm3) with the 3D LifeViz micro (QuantifiCare, Biot, France)

  4. Skin density

    Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

    Skin density was evaluated in percentage (%) using the Skin Scanner (tpm, Luneburg, Germany)

  5. Pore area

    Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

    Pore area was measured using the Antera 3D CS (Miravex, Dublin, Ireland), which quantifies pore area in millimeters squared (mm2).

  6. Eye and cheek area lifting

    Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

    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.

Secondary outcomes

  1. Global Aesthetic Improvement Scale

    Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

  2. Allergan Cheek Smoothness Scale

    Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment

Other outcomes

  1. Adverse event assessment

    Time frame: From baseline to 20 weeks post-treatment

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Korea International Cooperation Agency (KOICA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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