Systemic Isotretinoin Therapy and Eye

NCT07675460 | Completed

• 1 other identifier: 2024/1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye; Choroidal Thickness; Retinal Vascularisation; Acne Cystic; Isotretinoin

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  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

Study Arms (1)

Received systemic isotretinoin treatment for six months

OTHER

Drug: Isotretinoin (13-cis-retinoic acid)

Interventions

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.

Received systemic isotretinoin treatment for six months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years of age
• Having been diagnosed with cystic acne

You may not qualify if:

• 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.

Sponsors & Collaborators

• Demet Mutlu: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 30, 2026
• Study Start: April 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)