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

December 8, 2025 updated by: Venus Research Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Venus Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Expert Panel
A cohort of dermatology and aesthetic medicine experts participating in a Modified Delphi process to develop consensus recommendations on Isotretinoin in Rejuvenation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6-12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Venus Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Isotretinoin-Rejuvenation

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

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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