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Clinical Trials in Egypt / NCT07261748
Enrolling by invitation Observational

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

NCT07261748 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2025-11-01
Last updated
2025-12-03

Condition(s) studied

Aesthetic ProceduresCosmetic TechniquesSkin AgingRejuvenation

Study 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.

Eligibility

Sex
ALL
Min age
25 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Venus Research Center Cairo Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07261748 on ClinicalTrials.gov ↗ ← All trials in Egypt