- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296536
Expert Consensus on the Use of Isotretinoin in Rejuvenation: A Delphi Study
Study Overview
Status
Detailed Description
This study is a non-interventional, Delphi-based expert consensus project designed to establish recommendations for the use of isotretinoin in skin rejuvenation. While isotretinoin is primarily indicated for acne, accumulating clinical evidence and practitioner experience suggest that low-dose or micro-dose regimens may contribute to improvements in skin texture, fine lines, pore size, sebaceous activity, and overall skin quality. However, standardized guidance on indications, dosing, treatment duration, monitoring, and safety precautions is limited.
A panel of expert dermatologists with practical experience in isotretinoin therapy and skin rejuvenation will be invited to participate in multiple iterative Delphi rounds. Experts will rate agreement with proposed statements using a structured Likert scale. After each round, anonymized feedback will be provided, and statements not reaching consensus will be revised and re-evaluated until stable agreement is achieved.
The final output will consist of consensus-based recommendations reflecting practical, safe, and evidence-informed guidance for dermatologists considering isotretinoin for rejuvenation purposes. The study will also identify areas of uncertainty where further research is needed, supporting the safe expansion of isotretinoin applications beyond acne management.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Venus Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Target panel: 20-35 experienced dermatologists with practical knowledge of isotretinoin use for rejuvenation or acne.
Recruitment: Purposive sampling, stratified to ensure diversity in:
Practice setting (academic, private, public)
Geographic location
Years of experience
Baseline data collected: Age, sex, region, practice setting, years of experience, isotretinoin prescribing frequency, research or guideline involvement, declared conflicts of interest.
Panel retention strategy: Over-recruit by 10-20% to compensate for attrition; maintain anonymity of responses; clear instructions and timelines for participation.
Description
Inclusion Criteria:
Board-certified dermatologists or equivalent.
- 5 years clinical experience in dermatology.
Practical experience prescribing isotretinoin, including low- or micro-dose regimens for rejuvenation or acne.
Active engagement in clinical dermatology, teaching, research, or guideline development.
Willingness to participate in all Delphi rounds and provide informed consent.
Exclusion Criteria:
- Non-dermatology specialists.
Less than 5 years of clinical experience.
Lack of relevant isotretinoin experience.
Significant undisclosed conflict of interest with isotretinoin manufacturers.
Inability to participate in all Delphi rounds.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 Rejuvenation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Primary Outcome
Time Frame: 6-12 weeks
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Level of expert consensus on statements regarding the use of isotretinoin for skin rejuvenation, measured as the proportion of panelists reaching a predefined agreement threshold (e.g., ≥70-80%) per statement.
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6-12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Secondary Outcome
Time Frame: 6-12 weeks
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Consensus on patient selection criteria for rejuvenative isotretinoin. Consensus on dosing strategies (micro-dose, low-dose, cumulative dose, treatment duration). Consensus on monitoring protocols (clinical and laboratory). Consensus on safety measures, including pregnancy prevention and management of adverse effects. Consensus on integration with other rejuvenation therapies (topicals, procedures, photoprotection). Identification of areas without consensus, highlighting knowledge gaps and research priorities. |
6-12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Isotretinoin-Rejuvenation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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