IsotretinoinNCT07296536
Expert Consensus on the Use of Isotretinoin in Rejuvenation: A Delphi Study
An observational study of Isotretinoin and Isotretinoin Adverse Reaction, run by Venus Research Center at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Isotretinoin, Isotretinoin Adverse Reaction, Rejuvenation
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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.
Read the 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.
- Conditions
- Isotretinoin, Isotretinoin Adverse Reaction, Rejuvenation
- Keywords
- isotretinoin, rejuvenation, consensus, delphi method, Expert pannel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
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.
Measured: 6-12 weeks
Secondary outcomes (1)
Secondary Outcome
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.
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start25 Jan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsotretinoinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296536
- Sponsor's protocol ID
- Isotretinoin-Rejuvenation
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Consensus on the Use of Isotretinoin in Rejuvenation: A Delphi Study
- ClinicalTrials.gov ID
- NCT07296536
- Acronym / sponsor ID
- Isotretinoin-Rejuvenation
- Conditions
- Isotretinoin, Isotretinoin Adverse Reaction, Rejuvenation
- Keywords
- isotretinoin, rejuvenation, consensus, delphi method, Expert pannel
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Venus Research CenterUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expert Panel | – | –A cohort of dermatology and aesthetic medicine experts participating in a Modified Delphi process to develop consensus recommendations on Isotretinoin in Rejuvenation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Board-certified dermatologists or equivalent.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Secondary Outcome
Time frame: 6-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isotretinoin and Isotretinoin Adverse Reaction, run by Venus Research Center at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 6-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.