CompletedNot Applicable

Effect of Oral Isotretinoin on Ocular Surface and Meibomian Glands

Egypt60 participantsStarted 2024-01-01

Plain-language summary

The aim of the study was to evaluate meibomian gland morphology using non-contact meibography and ocular surface changes in patients with acne vulgaris treated with isotretinoin as indicators of dry eye, which is known to be a side effect of isotretinoin.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with clinically diagnosed acne vulgaris with various degrees of severity candidates for oral isotretinoin treatment. * Moderate to advanced stage of acne vulgaris. * No significant improvement with local and systemic antibiotic therapy. * Normal liver transaminase (AST, ALT) and lipid (Cholesterol, TG) levels Exclusion Criteria: * Patients with only comedonal acne. * Prior use of systemic isotretinoin. * Contact lens wearers. * History of ocular trauma or surgery (within 1 year). * Other systemic or dermatologic diseases. * Active conjunctivitis or allergy. * Use of medications affecting the ocular surface or meibomian glands. Lid deformity or abnormal lid movement

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1 Meibomian Gland Morphology (Meiboscore)

Timeframe: Baseline and 6 months

2 Ocular Surface Disease Index (OSDI) Score

Timeframe: Baseline and 6 months.

Trial details

NCT IDNCT07753811

SponsorBenha University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Dry Eye Disease (DED) trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.