Efficacy & Safety of hADM Skin Booster
- Conditions
- RhytidesSkin Texture IrregularitiesPhotoaged Facial SkinSkin Lifting and Tightening
- Interventions
- Drug: Elravie Re2ODrug: Elravie Balance
- Registration Number
- NCT07155278
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Male or female aged 30 to 65 years old
- Those with an Allergan Cheek Smoothness Scale (ACSS) score of 2-3 during screening
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment arm A Elravie Re2O One randomly assigned half of each participant's face received a combination of Elravie Re2O (phADM) and Elravie Balance (hyaluronic acid). Treatment arm A Elravie Balance One randomly assigned half of each participant's face received a combination of Elravie Re2O (phADM) and Elravie Balance (hyaluronic acid). Treatment arm B Elravie Balance The remaining half of each participant's face received Elravie Balance (hyaluronic acid) only.
- Primary Outcome Measures
Name Time Method Nasolabial fold depth 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)
Under-eye wrinkles 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.
Skin volume 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)
Skin density 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)
Pore area 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).
Eye and cheek area lifting 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Severance Hospital, Yonsei University College of Medicine
🇰🇷Seoul, South Korea
Severance Hospital, Yonsei University College of Medicine🇰🇷Seoul, South Korea