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Acne Drug's hidden toll on the eye revealed

NCT ID NCT07675460

Knowledge-focused Sponsor: Demet Mutlu 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study looks at how isotretinoin, a vitamin A-based acne medication, affects eye structures and tear production in people with severe cystic acne. Participants receive standard treatment and undergo eye exams, including dry eye tests and advanced imaging, before and during therapy. The goal is to catch potential eye side effects early by comparing those just starting treatment with those who have completed six months.

What this could mean

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

Active substance
isotretinoin (vitamin A derivative)
What this could lead to
If successful, this could help doctors detect and prevent eye-related side effects early in people taking isotretinoin for severe acne.
What could go wrong
This is a small, early-stage observational study, not a treatment trial. It may not lead to changes in clinical practice, and the eye changes measured may not predict real-world harm.

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

Apr 2024

Finished

Nov 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Being over 18 years of age * Having been diagnosed with cystic acne Exclusion Criteria: * History of glaucoma or ocular hypertension * Prior ocular surgical interventions * Any diagnosed ophthalmic condition, * Refractive errors exceeding 1.00 diopter axial length outside the 22 mm to 24 mm range * Oongoing dry eye therapy * Any systemic/local disorder known to impact retinal or choroidal vascularite or thickness.

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Conditions

The condition(s) this trial relates to.

acne dry eye syndrome retinal vascular disorder

As listed by the trial registrant

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

Acne cystic Choroidal thickness Dry eye Isotretinoin Retinal vascularisation

Contacts and locations

Locations

  • Kayseri City Hospital

    Kayseri, Turkey (Türkiye)

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