IsotretinoinNCT07296523
Expert Consensus on the Use of Isotretinoin in Acne Vulgaris: 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 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Isotretinoin, Isotretinoin Adverse Reaction, Acne
- 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 population: A purposive sample of experienced clinical dermatologists who actively manage acne and regularly prescribe oral isotretinoin. The panel will include clinicians with diverse practice settings and geographic representation relevant to the study scope. Panel size and rationale: Target enrolment: 20-35 experts. Rationale: this size balances breadth of opinion and feasibility for iterative Delphi rounds; it is large enough to capture diverse viewpoints yet small enough to allow meaningful, anonymized feedback and analysis. Minimum required for analysis: 15 panelists
Who may be able to join
- 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.
Who cannot join
- Inability or unwillingness to complete Delphi rounds.• Lack of clinical experience with isotretinoin.• Industry representatives without direct clinical practice
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 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.
Read the 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.
- Conditions
- Isotretinoin, Isotretinoin Adverse Reaction, Acne
- Keywords
- Acne, Consensus, Isotretinoin, Delphi
- Medical subject headings
- Acne Vulgaris
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 Acne Vulgaris. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Level of expert consensus on key clinical statements regarding isotretinoin use in acne vulgaris, measured by the proportion of panelists achieving the predefined agreement threshold (e.g., ≥70-80% agreement) for each statement across Delphi rounds.
Measured: 6-12 weeks
Secondary outcomes (1)
Secondary Outcome
Consensus on indications for isotretinoin therapy, including severity thresholds, risk of scarring, psychosocial impact, and treatment resistance.
Consensus on dosing strategies, including initial dosing, dose escalation, low-dose regimens, cumulative dose targets, and treatment duration.
Consensus on laboratory and clinical monitoring protocols, including baseline and follow-up testing frequency.
Consensus on pregnancy-prevention measures and counseling practices for females of childbearing potential.
Consensus on management of adverse effects, including mucocutaneous, psychiatric, musculoskeletal, and metabolic side effects.
Consensus on relapse prevention and retreatment strategies, including maintenance therapy and criteria for repeat courses.
Identification of areas of disagreement or uncertainty where consensus is not achieved, highlighting priorities for future research.
Measured: 6-8 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
- NCT07296523
- Sponsor's protocol ID
- Isotretinoin-ACNE-VenusRC
- 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 Acne Vulgaris: A Delphi Study
- ClinicalTrials.gov ID
- NCT07296523
- Acronym / sponsor ID
- Isotretinoin-ACNE-VenusRC
- Conditions
- Isotretinoin, Isotretinoin Adverse Reaction, Acne
- Keywords
- Acne, Consensus, Isotretinoin, Delphi
- 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 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.
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 Acne Vulgaris. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Target population: A purposive sample of experienced clinical dermatologists who actively manage acne and regularly prescribe oral isotretinoin. The panel will include clinicians with diverse practice settings and geographic representation relevant to the study scope. Panel size and rationale: Target enrolment: 20-35 experts. Rationale: this size balances breadth of opinion and feasibility for iterative Delphi rounds; it is large enough to capture diverse viewpoints yet small enough to allow meaningful, anonymized feedback and analysis. Minimum required for analysis: 15 panelists
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability or unwillingness to complete Delphi rounds.• Lack of clinical experience with isotretinoin.• Industry representatives without direct clinical practice
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 key clinical statements regarding isotretinoin use in acne vulgaris, measured by the proportion of panelists achieving the predefined agreement threshold (e.g., ≥70-80% agreement) for each statement across Delphi rounds.
1 secondary outcome
Secondary Outcome
Time frame: 6-8 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
Related trials for Isotretinoin
RecruitingPhase 3
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Acne Vulgaris
RecruitingObservational study
Facial Skin Microbiome in Patients With Moderate-to-Severe Acne Vulgaris Treated With Isotretinoin
Acne Vulgaris
RecruitingObservational study
The Impact of Baseline Hormonal Profiles (DHEAS, FSH, LH) on Treatment Response to Systemic Isotretinoin in Adult Female Patients With Acne Vulgaris
Acne Vulgaris
Active, not recruitingPhase 1
Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma
Recurrent Neuroblastoma, Refractory Neuroblastoma
Not yet recruitingPhase 4
Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety a n d Cure Rate in Adult Patients of Tinea Corporis/ Cruris-A Randomised Controlled Trail
Tinea Corporis
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 1 inclusion and 1 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.