Oral isotretinoin therapy and milia formation in patients with acne vulgaris: A prospective study

Fahad AlSaif; Abdulrhman AlDakhil; Nourah AlSyefi; AlBatool AlAmari; Ahmad AlAmari; Faisal AlSaif; Hend AlOtaibi; Amal Balbeesi; Nora AlBabtain

doi:10.4103/jdds.jdds_57_19

ORIGINAL ARTICLE

Year : 2021 | Volume : 25 | Issue : 1 | Page : 37-38

Oral isotretinoin therapy and milia formation in patients with acne vulgaris: A prospective study

Fahad AlSaif¹, Abdulrhman AlDakhil², Nourah AlSyefi³, AlBatool AlAmari², Ahmad AlAmari¹, Faisal AlSaif¹, Hend AlOtaibi¹, Amal Balbeesi¹, Nora AlBabtain¹
¹ Department of Dermatology, King Saud University, College of Medicine, Riyadh, Saudi Arabia
² Department of Dermatology, King Saud Medical City, Riyadh, Saudi Arabia
³ Department of Dermatology, King Abdullah Bin Abdulaziz University Hospital, Riyadh, Saudi Arabia

Date of Submission	27-Sep-2019
Date of Acceptance	26-Nov-2019
Date of Web Publication	04-May-2021

Correspondence Address:
Dr. Ahmad AlAmari
King Saud University, Riyadh
Saudi Arabia

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jdds.jdds_57_19

Abstract

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.

Keywords: Acne vulgaris, isotretinoin, milia

How to cite this article:
AlSaif F, AlDakhil A, AlSyefi N, AlAmari A, AlAmari A, AlSaif F, AlOtaibi H, Balbeesi A, AlBabtain N. Oral isotretinoin therapy and milia formation in patients with acne vulgaris: A prospective study. J Dermatol Dermatol Surg 2021;25:37-8

How to cite this URL:
AlSaif F, AlDakhil A, AlSyefi N, AlAmari A, AlAmari A, AlSaif F, AlOtaibi H, Balbeesi A, AlBabtain N. Oral isotretinoin therapy and milia formation in patients with acne vulgaris: A prospective study. J Dermatol Dermatol Surg [serial online] 2021 [cited 2023 Feb 1];25:37-8. Available from: https://www.jddsjournal.org/text.asp?2021/25/1/37/315330

Introduction

Milia are small cysts caused by keratin retention. They present with white papules of 1–2 mm and are quite common, affecting individuals of all ages and appearing most commonly on the face. They may appear spontaneously or secondary to trauma, ulceration, blistering diseases, or cosmetic procedures.^[1] Milia formation has also been reported as a side effect of topical corticosteroids, cyclosporine, sorafenib, penicillamine, and 5-fluorouracil.^[2] Although milia is not a serious condition, it can cause emotional distress, particularly in female patients.

Isotretinoin (13-cis-retinoic acid) is a revolutionary medication in dermatology.^[3] It targets the main pathophysiological mechanisms of acne vulgaris such as sebum production, follicular keratinization, and leukocytic chemotaxis-induced inflammation. Isotretinoin can be effective for rosacea, hidradenitis suppurativa, and Gram-negative folliculitis.^[4]

However, despite the effectiveness and popularity of this unique medication, isotretinoin has been associated with teratogenicity, xerosis, mood change, eczema, cheilitis, nose bleeding, muscle ache, dry eyes, and dyslipidemia.^[5] Little is known about the relationship between oral isotretinoin and milia formation.^[6] We assessed whether milia develop in patients treated with isotretinoin.

Methods

This was a prospective study conducted over a 1-year period. Patients were recruited from the outpatient dermatology clinic at King Saud University Hospital in Riyadh, Saudi Arabia, by dermatologists. We included young adults (18–25 years old) with moderate-to-severe acne vulgaris requiring oral isotretinoin therapy. Individuals were excluded from the study if they had a past history of blistering diseases or recent history of sunburn, ulceration, laser treatment, or cosmetic procedures in the past 1 month. Participants who applied topical medications such as phenols, hydroquinone, 5-fluorouracil, or corticosteroid creams in the past 1 month were also excluded from the study.

All patients received oral isotretinoin with a standard dose of 0.5 mg/kg/day and a cumulative dose of 120–150 mg/kg. Clinical assessment of milia was obtained by two blinded experienced dermatologists to minimize observer-expectancy bias at baseline and then at the 2^nd, 4^th, 6^th, and 8^th months of treatment.

Results

Twenty-one male patients and thirty female patients (total: 51 patients) were enrolled in the study. The mean age of the participants was 20.7 years (range: 18–25 years).

None of the patients who received oral isotretinoin therapy developed eruptive or new milia lesions.

Discussion

In one study of milia as a side effect of oral isotretinoin therapy, milia was observed in 8% of the patients.^[7] Eruptive milia occurred over the malar cheeks and inferior eyelids in a patient with severe nodulocystic acne after 4 months of treatment with systemic isotretinoin (dose: 80 mg/day). Three patients developed eruptive milia over the eyelids and periorbital area after receiving low-dose isotretinoin treatment for acne.^[8] We found no milia in over fifty prospectively followed isotretinoin-treated acne patients. Milia appear to be at worst an uncommon manifestation of isotretinoin treatment.

Our study had some limitations. First, the sample size was limited. Our study is not informative about milia formation with higher dose isotretinoin.

Conclusion

In conclusion, we found no association between oral isotretinoin at a standard dose of 0.5 mg/kg/day and secondary milia in patients with moderate to severe acne vulgaris. Further studies involving higher doses of oral isotretinoin are required to explore this possible association.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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