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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Nasolabial fold depth
Timeframe: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
2
Under-eye wrinkles
Timeframe: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
3
Skin volume
Timeframe: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
4
Skin density
Timeframe: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
5
Pore area
Timeframe: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
6
Eye and cheek area lifting
Timeframe: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment