MENA Consensus on Poly-L-Lactic Acid (PLLA) Biostimulator Use in Aesthetic Dermatology

This study aims to develop expert consensus on the safe and effective use of poly-L-lactic acid (PLLA) biostimulators in aesthetic dermatology across the Middle East and North Africa (MENA) region. PLLA is a commonly used injectable treatment that stimulates collagen production, but most guidelines come from Western populations and do not address the unique characteristics of Fitzpatrick III-VI skin types, which are predominant in the MENA region. The study uses a Modified Delphi method, a well-established approach for collecting and refining expert agreement. Dermatologists and aesthetic physicians from MENA countries will participate in two to three online rounds of surveys. In Round 1, experts will answer open-ended questions about indications, contraindications, dilution techniques, safety concerns, anatomical considerations, and training needs related to PLLA. Their responses will be analyzed and converted into structured statements. In Round 2, experts will rate each statement using a 1-to-9 Likert scale, indicating their level of agreement. Items with high agreement will form part of the final consensus. Statements with uncertain or conflicting ratings may undergo a third round for clarification. No patients are involved in the study, and no treatments or interventions will be administered. The study collects professional opinions only, and all responses are anonymized during analysis. The final output will be a region-specific clinical guideline to support safer and more standardized PLLA use across the MENA region. Results will be published in peer-reviewed journals and shared with the aesthetic medical community.

NCT Number	NCT07261748
Lead Sponsor	Venus Research Center
Conditions	Aesthetic Procedures, Cosmetic Techniques, Skin Aging, Rejuvenation
Enrollment	15 participants
Start Date	2025-11-01
Primary Completion	2026-07 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-12-03