Effects of Isotretinoin on Smell

ConditionSmell Dysfunction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorUşak University

About this trial

Isotretinoin is a common medicine used to treat moderate to severe acne. It often causes dryness of the skin and the inside of the nose. Because a normal sense of smell depends on a healthy nasal lining, this dryness may affect how well a person can smell.

This study will examine whether isotretinoin treatment changes the sense of smell in adults with acne. Before starting isotretinoin, participants will complete a standardized smell test and two short questionnaires about nasal symptoms and quality of life: the Nasal Obstruction Symptom Evaluation (NOSE) scale and the 22-item Sino-Nasal Outcome Test (SNOT-22). After at least 4 weeks of treatment, the same smell test and questionnaires will be repeated.

By comparing results before and after treatment, the study will test the hypothesis that isotretinoin has a negative effect on olfactory function and may reduce patients' ability to smell.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with acne and scheduled to start oral isotretinoin as part of routine dermatology care

Willing to participate and able to give informed consent

Not currently smoking

No history of allergic rhinitis, sinusitis, or active upper respiratory infection

Disqualifiers

Younger than 18 years or older than 45 years

Current cigarette smoking

History of chronic sinonasal disease

Any condition that would prevent completing the smell test

Trial design

Design model

Single group

Treatments tested in this trial

isotretinoin
Drug
Oral isotretinoin prescribed as standard-of-care treatment for acne vulgaris. The dosage, formulation, and duration of therapy will follow routine clinical practice and will be determined by the treating dermatologist based on the participant's clinical condition and body weight. Participants will typically receive daily oral isotretinoin for at least four weeks before the post-treatment assessments.

Treatment groups

54 Participants

are divided into 1 treatment group

Group A: Isotretinoin Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in Olfactory Function Score

Change in olfactory function from baseline to at least 4 weeks after initiation of oral isotretinoin therapy, measured using the Connecticut Chemosensory Clinical Research Center (CCCRC) smell test. The CCCRC test includes odor identification and odor discrimination components, and yields a composite score representing overall olfactory performance.

Time frame

Baseline and 4 weeks after starting isotretinoin treatment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uşak University

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator

Source ClinicalTrials.gov

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