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

NCT ID: NCT07296523

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-25

Study Completion Date

2027-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Isotretinoin Isotretinoin Adverse Reaction Acne

Keywords

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Acne Consensus Isotretinoin Delphi

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Venus Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Venus Research Center

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Isotretinoin-ACNE-VenusRC

Identifier Type: -

Identifier Source: org_study_id