Efficacy & Safety of hADM Skin Booster

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Photoaged Facial Skin; Skin Lifting and Tightening; Skin Texture Irregularities; Rhytides

Treatments: Drug: Elravie Balance; Drug: Elravie Re2O

Study type: Interventional

Funder types: Other

Identifiers

NCT07155278

1-2024-0042

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Treatment arm A

Experimental group

Description:

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

Treatment:

Drug: Elravie Re2O

Drug: Elravie Balance

Treatment arm B

Active Comparator group

Description:

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

Treatment:

Drug: Elravie Balance