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

NCT07261748 | Enrolling By Invitation

• 1 other identifier: PLLA-VenusRC
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Aesthetic Procedures; Rejuvenation; Cosmetic Techniques; Skin Aging

Keywords

Poly-L-lactic acid; PLLA; Biostimulator; Aesthetic dermatology; Collagen biostimulation; MENA region; Delphi study; Expert consensus; Cosmetic injectables; Facial rejuvenation

Outcome Measures

Primary Outcomes (1)

• Achievement of Consensus on PLLA Clinical Practice Statements

  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."

  6-12 weeks

Secondary Outcomes (1)

• Expert Rating Distribution Across PLLA Practice Domains

  6-12 weeks

Study Arms (1)

Expert Panel

A cohort of dermatology and aesthetic medicine experts from the MENA region participating in a Modified Delphi process to develop consensus recommendations on PLLA biostimulator use.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A purposively selected group of dermatology and aesthetic medicine experts from Egypt and the broader MENA region. Participants are clinicians with significant experience using poly-L-lactic acid (PLLA) biostimulators and are invited to contribute to a structured Modified Delphi process to develop regional consensus recommendations.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Venus Research Center: lead

Study Sites (1)

Venus Research Center

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)