Systemic Isotretinoin Therapy and Eye

June 26, 2026 updated by: Demet Mutlu

Effects of Systemic Isotretinoin Therapy on Choroidal Thickness and Retinal Vascular Parameters in Nodulocystic Acne Patients:A Prospevtive Study

The dermatologist created a treatment plan for participants diagnosed with acne using medications containing vitamin A. While this medication has many benefits for the skin, it also has various side effects affecting many other systems. One of the most important of these side effects is related to the eyes. Therefore, the dermatologist will refer participants to an eye clinic for eye exams before and at regular intervals after starting this medication. During these exams, the investigators will perform eye measurements, a dry eye test, and an eye CT scan (OCTA). This study will compare patients who are scheduled to start treatment with vitamin A-containing pills for acne treatment with patients who have started treatment and completed their sixth month. This will allow for the early detection of potential side effects associated with this medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Received systemic isotretinoin treatment for six months
Drug: Isotretinoin (13-cis-retinoic acid)
No different dosage was used compared to other studies. In addition, more ocular layers were examined using imaging techniques to allow for early diagnosis of possible drug-related side effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: From enrollment to the end of treatment at 24 weeks
In the participant group receiving treatment for through study completion, any statistically significant change in DVD, SVD, CVD values or Shirmer test scores in OCTA data will be considered a treatment-related side effect.
From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Demet Mutlu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the personal data protection laws in our country, sharing this information is not considered.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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