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Enrolling by Invitation

NCT Number: NCT07296536

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

This expert consensus project explores the role of low-dose isotretinoin as a rejuvenative and preventive strategy for photoaging and sebaceous-driven skin changes. While isotretinoin is traditionally used for acne, increasing clinical experience suggests that carefully selected micro-dose and low-dose regimens may improve skin texture, pore size, sebaceous activity, and overall skin quality, with potential benefits in skin aging and maintenance rejuvenation programs.

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Venus Research Center

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Primary Outcome

    Time frame: 6-12 weeks

    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.

Secondary outcomes

  1. Secondary Outcome

    Time frame: 6-12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Venus Research Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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