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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acne; Isotretinoin Adverse Reaction; Isotretinoin

Detailed Description

This study is a non-interventional, methodological expert consensus project that employs a modified Delphi technique to develop standardized, evidence-informed recommendations for the use of isotretinoin in the management of acne vulgaris. Although isotretinoin is widely recognized as the most effective systemic therapy for severe and treatment-resistant acne, considerable variability exists in clinical practice regarding its indications, dosing strategies, treatment duration, laboratory monitoring, pregnancy-prevention measures, and long-term maintenance. These variations reflect differences in training, regional practice patterns, and evolving evidence.

The Delphi method was selected to achieve structured consensus while minimizing the influence of dominant individuals and allowing anonymous, iterative feedback. A steering committee will first conduct a comprehensive literature review and draft a series of clear, clinically relevant statements addressing key domains of isotretinoin use. These domains will include patient selection (severity, age, psychosocial impact), baseline evaluation, dosing approaches (standard-dose, low-dose, and flexible regimens), cumulative dose considerations, treatment duration, management of adverse effects, laboratory and clinical monitoring, mental health considerations, pregnancy-prevention strategies, relapse risk, retreatment, and maintenance therapy.

A panel of expert dermatologists with demonstrated clinical experience in acne management and isotretinoin prescribing will be invited to participate. Panelists will independently rate their level of agreement with each statement using a structured Likert scale during successive Delphi rounds. After each round, responses will be analyzed quantitatively, and anonymized feedback will be provided to participants. Statements not reaching predefined consensus thresholds will be revised based on panel input and re-evaluated in subsequent rounds until consensus or stability of responses is achieved.

The final output of this study will consist of consensus-based recommendations reflecting areas of strong agreement as well as identified areas of uncertainty or disagreement. These recommendations aim to support dermatologists in making patient-centered, safe, and effective decisions regarding isotretinoin therapy, promote consistency in clinical practice, and serve as a foundation for future guidelines and research initiatives.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Venus Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome	Consensus on indications for isotretinoin therapy, including severity thresholds, risk of scarring, psychosocial impact, and treatment resistance. Consensus on dosing strategies, including initial dosing, dose escalation, low-dose regimens, cumulative dose targets, and treatment duration. Consensus on laboratory and clinical monitoring protocols, including baseline and follow-up testing frequency. Consensus on pregnancy-prevention measures and counseling practices for females of childbearing potential. Consensus on management of adverse effects, including mucocutaneous, psychiatric, musculoskeletal, and metabolic side effects. Consensus on relapse prevention and retreatment strategies, including maintenance therapy and criteria for repeat courses. Identification of areas of disagreement or uncertainty where consensus is not achieved, highlighting priorities for future research.	6-8 weeks

Collaborators and Investigators

• Sponsor: Venus Research Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Acne; Consensus; Isotretinoin; Delphi
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris
• Other Study ID Numbers: Isotretinoin-ACNE-VenusRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Delphi studies do not collect patient data, medical records, biological samples, or identifiable clinical information. Experts only give opinions, not "IPD." Their responses are anonymized, and sharing identifiable expert-level responses is not required and often discouraged

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No