Efficacy & Safety of hADM Skin Booster

NCT ID: NCT07155278

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-21
• Study Completion Date: 2025-05-07

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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment arm A

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

Group Type: EXPERIMENTAL

Elravie Re2O

Intervention Type: 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

Intervention Type: 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 B

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

Group Type: ACTIVE_COMPARATOR

Elravie Balance

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea International Cooperation Agency (KOICA)

UNKNOWN

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Ngoc Ha Nguyen

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ju Hee Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2024-0042

Identifier Type: -

Identifier Source: org_study_id