Real-World Safety of Oral Isotretinoin in Patients During Sunny Months: Retrospective Cohort Study

Elisa Marzola; Emma Pedarzani; Giorgia Valpiani; Sofia Fraternale; Giulia Toni; Vincenzo Bettoli; Monica Corazza; Alessandro Borghi

doi:10.5826/dpc.1504a5612

Real-World Safety of Oral Isotretinoin in Patients During Sunny Months: Retrospective Cohort Study

Authors

Elisa Marzola Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy https://orcid.org/0000-0002-5905-6186
Emma Pedarzani Research and Innovation Unit, Biostatistics and Clinical Trial Area, University Hospital of Ferrara, Ferrara, Italy https://orcid.org/0009-0006-8211-6139
Giorgia Valpiani Research and Innovation Unit, Biostatistics and Clinical Trial Area, University Hospital of Ferrara, Ferrara, Italy https://orcid.org/0000-0002-1401-8012
Sofia Fraternale Research and Innovation Unit, Biostatistics and Clinical Trial Area, University Hospital of Ferrara, Ferrara, Italy
Giulia Toni Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy https://orcid.org/0000-0003-4152-1761
Vincenzo Bettoli Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy https://orcid.org/0000-0002-2760-4600
Monica Corazza Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy https://orcid.org/0000-0003-2105-6217
Alessandro Borghi Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy https://orcid.org/0000-0002-5333-3074

Keywords:

oral isotretinoin, acne, seasonality, side effects, photosensitivity

Abstract

Introduction: There is a widespread clinical practice of avoiding oral isotretinoin administration during the sunny season due to its purported photosensitizing effect. However, this approach is not supported by solid evidence.

Objective: The aim of this study was to assess the safety and effectiveness of administering oral isotretinoin at a reduced daily dosage during the sunny period in a real-world clinical setting.

Methods: This retrospective cohort study included all acne patients treated with oral isotretinoin at our Acne Clinic (January 2014 - December 2023) who had received the drug between June and September, when UV index exceeds a threshold of 6. Conventionally, oral isotretinoin daily dosage is reduced by approximately half during these four sunny months and then increased again. We compared the occurrence of side effects or treatment discontinuation between sunny and non-sunny periods. The therapeutic response was explored in relation to the daily dosage.

Results: 359 patients (61.3% males, with a mean age of 19.0 years, standard deviation (SD) 6.7) were included. Adverse events were reported by 39.2% and 28.3% of patients during the non-sunny and sunny months, respectively. The incidence of treatment discontinuation was negligible. The reduction in acne severity was independent of the daily dosage of oral isotretinoin.

Conclusions: The study results support the lack of any necessity to suspend or refrain from administering oral isotretinoin during sunny seasons. The preventive reduction of its daily dosage during sunny periods does not negatively affect the drug's effectiveness. Oral isotretinoin can be taken, at a slightly reduced dosage, during sunny months.

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