MENA Consensus on Poly-L-Lactic Acid (PLLA) Biostimulator Use in Aesthetic Dermatology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Achievement of Consensus on PLLA Clinical Practice Statements
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Achievement of Consensus on PLLA Clinical Practice Statements
Time Frame: 6-12 weeks
The primary outcome is the proportion of Delphi statements reaching consensus among expert panelists. Consensus is defined using RAND/UCLA criteria: a median rating of 7-9 on a 9-point Likert scale with a Disagreement Index (DI) \< 1.0. Statements will be categorized as "consensus appropriate," "consensus inappropriate," or "no consensus."
Secondary Outcomes
- Expert Rating Distribution Across PLLA Practice Domains(6-12 weeks)