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| Name | Class |
|---|---|
| Korea International Cooperation Agency (KOICA) | UNKNOWN |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Treatment arm B | Active Comparator | The remaining half of each participant's face received Elravie Balance (hyaluronic acid) only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elravie Re2O | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Nasolabial fold depth | Nasolabial fold depth was measured using the Antera 3D CS (Miravex, Dublin, Ireland), which quantifies wrinkle depth in millimeters (mm) | 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. | 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) | 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) | 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). | 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. | Baseline and 1, 4, 8, 12, 16, and 20 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event assessment | The safety of the test products was assessed throughout the study period. During each visit, participants were monitored for any adverse reactions, and the use of any concomitant medications that could potentially affect the study was checked. All confirmed and reported adverse reactions from all subjects were compiled to determine the incidence rate, which was then used as data for the overall safety evaluation of the product. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ju Hee Lee, M.D., Ph.D. | Department of Dermatology & Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
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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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.
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| Elravie Balance | 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. |
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| From baseline to 20 weeks post-treatment |