RhytidesPhase 4NCT07155278
Efficacy & Safety of hADM Skin Booster
A Phase 4 study testing Elravie Re2O and Elravie Balance in people with Rhytides and Skin Texture Irregularities, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Rhytides, Skin Texture Irregularities, Photoaged Facial Skin
- What is being tested?
- Elravie Re2O and Elravie Balance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Nov 2024to 7 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 30 to 65 years old
- Those with an Allergan Cheek Smoothness Scale (ACSS) score of 2-3 during screening
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
Official title: Efficacy and Safety of a Particulated Human Acellular Dermal Matrix Skin Booster: A Randomized, Split-Face, Double-blinded, Prospective Clinical Trial
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:
Read more
- Does phADM combined with HA improve objective skin measurements and subjective skin assessments more effectively than HA alone?
- 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:
- Be randomly assigned to receive three intradermal injections at one-month intervals, with phADM + HA on one cheek and HA alone on the other.
- 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).
- Be monitored for local adverse events and changes in vital signs to assess safety.
- Being tested
- Elravie Re2O, Elravie Balance
- Keywords
- Acellular dermal matrix, Dermal filler, Skin booster, Hyaluronic acid, Skin rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elravie Re2ODrug
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 BalanceDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm A | Experimental | One randomly assigned half of each participant's face received a combination of Elravie Re2O (phADM) and Elravie Balance (hyaluronic acid). Receives: Drug: Elravie Re2O; Drug: Elravie Balance |
| Treatment arm B | Active comparator | The remaining half of each participant's face received Elravie Balance (hyaluronic acid) only. Receives: Drug: Elravie Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasolabial fold depth
Nasolabial fold depth was measured using the Antera 3D CS (Miravex, Dublin, Ireland), which quantifies wrinkle depth in millimeters (mm)
Measured: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Under-eye wrinkles
The Eve V (EVELAB INSIGHT, Singapore) was used to measure under-eye wrinkles in pixels.
Measured: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Skin volume
Skin volume was measured in cubic millimeters (mm3) with the 3D LifeViz micro (QuantifiCare, Biot, France)
Measured: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Skin density
Skin density was evaluated in percentage (%) using the Skin Scanner (tpm, Luneburg, Germany)
Measured: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Pore area
Pore area was measured using the Antera 3D CS (Miravex, Dublin, Ireland), which quantifies pore area in millimeters squared (mm2).
Measured: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Eye and cheek area lifting
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.
Measured: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Secondary outcomes (2)
Global Aesthetic Improvement Scale
Measured: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Allergan Cheek Smoothness Scale
Measured: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start21 Nov 2024
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each right or left side of the eligible participants' faces was randomly assigned one of the two treatment arms. The test side of each participant's face received a combination of Elravie Re2O (containing phADM) and Elravie Balance (Hyaluronic acid), while the control side received only Elravie Balance.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea International Cooperation Agency
- Responsible party
- Principal investigator, Ngoc Ha Nguyen, Yonsei University
- Investigators
- Ju Hee Lee, M.D., Ph.D., Principal investigator, Department of Dermatology & Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155278
- Sponsor's protocol ID
- 1-2024-0042
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies that restrict data sharing beyond the research team. Data were collected under a protocol that did not include participant consent for public or external data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Particulated Human Acellular Dermal Matrix Skin Booster: A Randomized, Split-Face, Double-blinded, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07155278
- Acronym / sponsor ID
- 1-2024-0042
- Keywords
- Acellular dermal matrix, Dermal filler, Skin booster, Hyaluronic acid, Skin rejuvenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Korea International Cooperation Agency
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does phADM combined with HA improve objective skin measurements and subjective skin assessments more effectively than HA alone?
- 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:
- Be randomly assigned to receive three intradermal injections at one-month intervals, with phADM + HA on one cheek and HA alone on the other.
- 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).
- Be monitored for local adverse events and changes in vital signs to assess safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each right or left side of the eligible participants' faces was randomly assigned one of the two treatment arms. The test side of each participant's face received a combination of Elravie Re2O (containing phADM) and Elravie Balance (Hyaluronic acid), while the control side received only Elravie Balance.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm A | Experimental | Drug: Elravie Re2O, Drug: Elravie BalanceOne randomly assigned half of each participant's face received a combination of Elravie Re2O (phADM) and Elravie Balance (hyaluronic acid). |
| Treatment arm B | Active comparator | Drug: Elravie BalanceThe remaining half of each participant's face received Elravie Balance (hyaluronic acid) only. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 30 to 65 years old
- Those with an Allergan Cheek Smoothness Scale (ACSS) score of 2-3 during screening
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elravie Re2OElravie 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. | Drug | Treatment arm A |
| Elravie BalanceElravie 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. | Drug | Treatment arm A, Treatment arm B |
Primary outcome
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)
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.
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)
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)
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).
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.
2 secondary outcomes
Global Aesthetic Improvement Scale
Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Allergan Cheek Smoothness Scale
Time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies that restrict data sharing beyond the research team. Data were collected under a protocol that did not include participant consent for public or external data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju Hee Lee, M.D., Ph.D. principal investigator
Department of Dermatology & Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elravie Re2O and Elravie Balance in people with Rhytides and Skin Texture Irregularities, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasolabial fold depth (time frame: Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.