Acne VulgarisNCT06725290
Dry Eye Disease With Isotretinoin ISOTRETINOIN
An observational study of Acne Vulgaris, run by Cairo University.
Trial summary
The study aims to explore the effects of isotretinoin therapy on the dry eye parameters in acne vulgaris patients \& determine if it is dose-dependent or not. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Ocular Surface Disease Index (OSDI) questionnaire
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Sep 2025
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Acne patients on isotretinoin
Who may be able to join
- Moderate to severe acne on isotretinoin
Who cannot join
- Occular diseases causing dry eye
- Pregnant females
About this study
Official title: Digital Assessment of Dry Eye Diseases in Acne Vulgaris Patients Receiving Isotretinoin Therapy
The study aims to explore the effects of isotretinoin therapy on the dry eye parameters in acne vulgaris patients \& determine if it is dose-dependent or not.
Read the detailed description
To measure the tear film, the eye lid thickness, the meibomian gland function and to do objective tests for comparison
- Conditions
- Acne Vulgaris
- Being tested
- Ocular Surface Disease Index (OSDI) questionnaire
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular Surface Disease Index (OSDI) questionnaireDiagnostic test
The OSDI is a validated, self-administered questionnaire for assessing the presence and severity of ocular surface disease symptoms. The OSDI questionnaire includes 12 questions about the respondent's past week experience with the ocular symptoms, vision-related function, and environmental triggers
| Study group | Role | What they receive |
|---|---|---|
| low dose isotretinoin | Acne patients taking 20 mg daily isotretinoin Receives: Diagnostic Test: Ocular Surface Disease Index (OSDI) questionnaire | |
| high dose isotretinoin | Acne patients taking 0.5 mg/kg daily dose of isotretinoin Receives: Diagnostic Test: Ocular Surface Disease Index (OSDI) questionnaire | |
| Normal control | Not described Receives: Diagnostic Test: Ocular Surface Disease Index (OSDI) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total ocular surface disease index (OSDI) SCORE
Total OSDI score ranged from 0 to 100 with means greater symptom severity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725290
- Sponsor's protocol ID
- Dry eye with isotretinoin
- Status last verified
- May 2025
- First submitted
- 8 Dec 2024
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Assessment of Dry Eye Diseases in Acne Vulgaris Patients Receiving Isotretinoin Therapy
- ClinicalTrials.gov ID
- NCT06725290
- Acronym / sponsor ID
- Dry eye with isotretinoin
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 10 Dec 2024 (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.
The study aims to explore the effects of isotretinoin therapy on the dry eye parameters in acne vulgaris patients \& determine if it is dose-dependent or not.
Detailed description
To measure the tear film, the eye lid thickness, the meibomian gland function and to do objective tests for comparison
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose isotretinoin | – | Diagnostic Test: Ocular Surface Disease Index (OSDI) questionnaireAcne patients taking 20 mg daily isotretinoin |
| high dose isotretinoin | – | Diagnostic Test: Ocular Surface Disease Index (OSDI) questionnaireAcne patients taking 0.5 mg/kg daily dose of isotretinoin |
| Normal control | – | Diagnostic Test: Ocular Surface Disease Index (OSDI) questionnaire |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Acne patients on isotretinoin
Key inclusion criteria (1 listed)
- Moderate to severe acne on isotretinoin
Key exclusion criteria (2 listed)
- Occular diseases causing dry eye
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular Surface Disease Index (OSDI) questionnaireThe OSDI is a validated, self-administered questionnaire for assessing the presence and severity of ocular surface disease symptoms. The OSDI questionnaire includes 12 questions about the respondent's past week experience with the ocular symptoms, vision-related function, and environmental triggers | Diagnostic test | Normal control, high dose isotretinoin, low dose isotretinoin |
Primary outcome
Total ocular surface disease index (OSDI) SCORE
Time frame: 3 months
Total OSDI score ranged from 0 to 100 with means greater symptom severity
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 14 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Cairo University.
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 2 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: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Total ocular surface disease index (OSDI) SCORE (time frame: 3 months). 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 14 May 2025.