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Can acne drug harm the eyes? new study investigates

NCT ID NCT07753811

Knowledge-focused Sponsor: Benha University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study looks at how oral isotretinoin, a common acne treatment, affects the surface of the eye and the meibomian glands, which produce the oily layer of tears. Researchers will measure tear film stability, gland structure, and dry eye symptoms in 60 acne patients before and after six months of treatment. The goal is to better understand and potentially predict dry eye as a side effect of isotretinoin.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral isotretinoin
What this could lead to
If this trial succeeds, it could help doctors predict or manage dry eye as a side effect of isotretinoin, improving quality of life for acne patients.
What could go wrong
This is a small, early-stage observational study, so results may not apply broadly. It does not test a new treatment, and findings may not change clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jan 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris dry eye syndrome Meibomian Gland Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acne vulgaris Dry eye disease (DED) Meibomian gland dysfunction (disorder)

Contacts and locations

Locations

  • faculty of Medicine

    Banhā, 13518, Egypt

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