Efficacy and Safety of a Particulated Human Acellular Dermal Matrix Skin Booster: A Randomized, Split-Face, Double-blinded, Prospective Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Nasolabial fold depth
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 30 to 65 years old
- •Those with an Allergan Cheek Smoothness Scale (ACSS) score of 2-3 during screening
排除标准
- •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
研究组 & 干预措施
Treatment arm A
One randomly assigned half of each participant's face received a combination of Elravie Re2O (phADM) and Elravie Balance (hyaluronic acid).
干预措施: Elravie Re2O (Drug)
Treatment arm A
One randomly assigned half of each participant's face received a combination of Elravie Re2O (phADM) and Elravie Balance (hyaluronic acid).
干预措施: Elravie Balance (Drug)
Treatment arm B
The remaining half of each participant's face received Elravie Balance (hyaluronic acid) only.
干预措施: Elravie Balance (Drug)
结局指标
主要结局
Nasolabial fold depth
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)