Expert Consensus on the Use of Isotretinoin in Acne Vulgaris: A Delphi Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Isotretinoin, Isotretinoin Adverse Reaction, Acne. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Primary outcome measures
- Primary Outcome [Time frame: 6-12 weeks]
Secondary outcome measures (1)
- Secondary Outcome [Time frame: 6-8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Egypt · 1 center
- Venus Research Center — Cairo
Identifiers
NCT: NCT07296523 · Isotretinoin-ACNE-VenusRC