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Completed

NCT Number: NCT07675460

Systemic Isotretinoin Therapy and Eye

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.

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Key information

Conditions

Dry Eye Acne Cystic Choroidal Thickness Dry Eye Syndromes Eye Diseases Isotretinoin Lacrimal Apparatus Diseases Retinal Vascularisation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isotretinoin (13-cis-retinoic acid)

Drug

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Demet Mutlu

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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