Safety and Efficacy of Micronized Acellular Dermal Matrix Injection for Correction of Moderate to Severe Nasolabial Folds: A Double-Blind, Multicenter, Randomized Controlled, Non-inferior Clinical Trial

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background Nasolabial folds (NLFs) are prominent facial lines that deepen with age and may adversely affect facial aesthetics and psychosocial confidence. Injectable fillers, including micronized acellular dermal matrix (mADM), offer minimally invasive correction; however, clinical evidence for mADM's safety and efficacy remains limited. We conducted a double-blind, multicenter, randomized controlled trial to compare an mADM filler (Regenfil) with a regulatory agency-approved cross-linked collagen filler (Sunmax Collagen Implant I-Plus). Methods Adults aged ≥18 years with Wrinkle Severity Rating Scale (WSRS) grade 3 or 4 NLFs were randomized to receive mADM or collagen. Six weeks after the initial treatment, a protocol-defined supplemental injection was permitted if additional correction was needed. Outcomes were assessed 6 weeks, 3 months, and 6 months after the last treatment. Efficacy endpoints included blinded-evaluator WSRS, Global Aesthetic Improvement Scale (GAIS) rated by injectors and participants, and participant satisfaction. The prespecified primary endpoint was the percentage of participants achieving a >1-grade WSRS improvement simultaneously on both left and right NLFs. Safety was evaluated by monitoring device-related adverse events and local injection-site reactions. Results Of 202 randomized participants, 175 completed all required follow-ups for safety and ef

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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