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

Study Overview This study is a non-interventional, observational expert consensus project designed to develop region-specific guidelines for the use of poly-L-lactic acid (PLLA) biostimulators in aesthetic dermatology across the Middle East and North Africa (MENA) region. PLLA is widely used for collagen stimulation and facial rejuvenation, but existing evidence and guidelines are derived primarily from Western populations. Given that Fitzpatrick III-VI skin types dominate the MENA region, and that anatomical, cultural, and safety considerations differ, a structured expert consensus is required to optimize clinical practice.

Study Design

This study uses a Modified Delphi methodology, incorporating principles from the RAND/UCLA Appropriateness Method. The Delphi process includes 2-3 survey rounds:

Round 1 (Qualitative Item Generation):

Experts complete an open-ended questionnaire addressing indications, contraindications, dilution protocols, injection techniques, safety concerns (including risk of papules and PIH), anatomical considerations, combination treatments, follow-up practices, regulatory issues, training requirements, and research priorities. Responses undergo thematic analysis to generate structured candidate statements.

Round 2 (Quantitative Consensus Rating):

The consolidated statements are rated using a 9-point Likert scale (1 = inappropriate, 9 = appropriate). Experts rate each item independently based on clinical relevance, safety, and applicability in MENA populations.

Optional Round 3:

Statements without clear consensus are redistributed with anonymized group statistics for re-rating. This step is used only if needed to refine borderline items.

Expert Panel Selection

Experts will be eligible if they meet at least two of the following:

• ≥5 years of aesthetic practice;
• ≥50 PLLA cases performed;
• Recognized trainer, lecturer, or KOL;
• Publications or academic contributions in aesthetic medicine;
• Active practice within Egypt or other MENA countries. Panel size will be 15-25 experts, ensuring geographic, academic, and experiential diversity.

Consensus Definitions

The study follows RAND/UCLA criteria:

• Consensus (Appropriate): Median 7-9 AND Disagreement Index (DI) < 1.0
• Consensus (Inappropriate): Median 1-3 AND DI < 1.0
• No Consensus: Median 4-6 OR DI ≥ 1.0
• Items with near-consensus may undergo a third Delphi round. Data Collection Tools

VRC-developed materials include:

• Full A-L Likert questionnaire
• Fillable PDF form
• Online REDCap/Google Forms instrument
• Round-2 survey booklet
• Excel master sheet for response tracking Statistical Analysis For each item, the following will be calculated: median, interquartile range, interpercentile range (IPR), IPR adjusted for symmetry (IPRAS), and the Disagreement Index. Items will be categorized by agreement level and summarized for publication. Subgroup analyses (e.g., GCC vs North Africa) may be performed.

Ethical Considerations This study does not involve patients, clinical interventions, or personal health information. Participation is voluntary. Expert responses are anonymized. No foreseeable risks are associated with participation, and the study qualifies as minimal-risk, non-interventional research.

Outcomes and Dissemination The primary outcome is a set of consensus-based, region-specific recommendations for PLLA use in aesthetic practice. Secondary outcomes include identification of training standards and research priorities. Results will be disseminated through peer-reviewed publications, conference presentations, and a VRC-branded clinical guideline.

Inclusion criteria

• Board-certified dermatologist or plastic surgeon OR physician practicing aesthetic medicine.
• Minimum of 5 years of clinical experience OR ≥50 documented PLLA cases.
• Practicing within Egypt or the Middle East and North Africa (MENA) region.
• Willingness to participate in Delphi rounds and provide expert ratings.
• Ability to read and respond to surveys in English.

Exclusion criteria

• Inability or unwillingness to complete Delphi rounds.
• Lack of clinical experience with PLLA.
• Industry representatives without direct clinical practice.