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Background: Isotretinoin (13-cis-retinoic acid) is effective in acne treatment. Isotretinoin can cause hair loss, xerosis, cheilitis, and nail changes. Milia is a reported side effect; however, little is known about the relationship between oral isotretinoin and milia formation. Purpose: The objective was to investigate milia as a potential side effect of oral isotretinoin treatment. Methods: Fifty-one patients (male/female: 21/30) aged 18–25 years with moderate-to-severe acne vulgaris were treated with a standard dose of oral isotretinoin 0.5 mg/kg/day and a cumulative dose of 120–150 mg/kg. Clinical assessments of milia were obtained at 0, 2, 4, 6, and 8 months of treatment. Results: None of the patients who received oral isotretinoin therapy developed milia. Conclusion: We found no association between oral isotretinoin at a standard dose of 0.5 mg/kg/day and milia formation in patients with moderate-to-severe acne vulgaris.

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