Expert Consensus on the Use of Isotretinoin in Acne Vulgaris: A Delphi Study

NCT07296523 | Enrolling By Invitation

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

Brief Summary

This study is a Delphi-based expert consensus project designed to establish evidence-informed, practical recommendations for the use of isotretinoin in acne vulgaris. Despite isotretinoin being the most effective therapy for severe and refractory acne, variations persist in its indications, dosing strategies, monitoring protocols, and safety counseling.

Conditions

Isotretinoin; Isotretinoin Adverse Reaction; Acne

Keywords

Acne; Consensus; Isotretinoin; Delphi

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Level of expert consensus on key clinical statements regarding isotretinoin use in acne vulgaris, measured by the proportion of panelists achieving the predefined agreement threshold (e.g., ≥70-80% agreement) for each statement across Delphi rounds.

  6-12 weeks

Secondary Outcomes (1)

• Secondary Outcome

  6-8 weeks

Study Arms (1)

Expert Panel

A cohort of dermatology and aesthetic medicine experts participating in a Modified Delphi process to develop consensus recommendations on Isotretinoin in Acne Vulgaris.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Target population: A purposive sample of experienced clinical dermatologists who actively manage acne and regularly prescribe oral isotretinoin. The panel will include clinicians with diverse practice settings and geographic representation relevant to the study scope. Panel size and rationale: Target enrolment: 20-35 experts. Rationale: this size balances breadth of opinion and feasibility for iterative Delphi rounds; it is large enough to capture diverse viewpoints yet small enough to allow meaningful, anonymized feedback and analysis. Minimum required for analysis: 15 panelists

You may qualify if:

• Board-certified or equivalent dermatologist, Minimum of 5 years of post-certification clinical experience in the management of acne vulgaris, Regular prescribing experience with oral isotretinoin in routine clinical practice, Willingness to participate in all Delphi rounds.

You may not qualify if:

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

Sponsors & Collaborators

• Venus Research Center: lead

Study Sites (1)

Venus Research Center

Cairo, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

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

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: January 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)