A Double-Blind Randomized Study of Two Doses of Oral Isotretinoin in the Treatment of Recalcitrant Facial Flat Warts: Impact on Quality of Life, Anxiety, and Depression

IF 2.1 Q2 MEDICINE, GENERAL & INTERNAL

Health Science Reports Pub Date : 2025-04-21 DOI:10.1002/hsr2.70684

María Guadalupe Olguín-García, María Luisa Peralta-Pedrero, Martha Alejandra Morales-Sánchez, Elisa Vega-Memije, Víctor Manuel Bautista-de Lucio

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Abstract

Background and Aims

Recalcitrant facial flat warts are caused by human papillomavirus and may persist for years despite treatment. Oral isotretinoin administered at a dose of 0.5 mg/kg/day is effective and safe. However, the adverse effects reported are dose-dependent behaviors and they could limit their use. We aim to compare the efficacy and safety of two doses of oral isotretinoin for the treatment of recalcitrant facial flat warts and to assess the quality of life, anxiety, and depression in the individuals studied.

Methods

Isotretinoin 0.3 mg/kg/day or isotretinoin 0.5 mg/kg/day was administered to 21 and 19 adult patients, respectively, in a double-blind, randomized fashion for 12 weeks. Cutaneous lesions were assessed, and adverse events, including serologic changes, were recorded. It is considered that warts were recalcitrant if the patient was treated for at least 3 years with at least two of the following options: retinoids, 5-fluorouracil, imiquimod, and cryotherapy. In addition, quality of life, anxiety, and depression were assessed at the beginning and end of follow-up.

Results

In the isotretinoin 0.3 mg/kg/day group, 35% of the patients had a complete response, and 66% had a partial response, while in the isotretinoin 0.5 mg/kg/day group, 73.7% presented a complete response, and 26.31% presented a partial response (p = 0.015). The most frequent adverse event was cheilitis. There was an elevation of aspartate aminotransferase (p = 0.020) and total bilirubin (p = 0.015) in the isotretinoin 0.5 mg/kg/day group. Improvement in the quality-of-life score (p = 0.0001) and a reduction in the anxiety (p = 0.00) score was observed in both groups.

Conclusion

Oral isotretinoin at a dose of 0.5 mg/kg/day is safe and effective for the treatment of recalcitrant facial flat warts in adults, with lower recurrence rates than 0.3 mg/kg/day. Prolonged treatment with isotretinoin for over 12 weeks in adults can increase the overall response rate.

Trial Registration: Registry of ClinicalTrials.gov identifier: NTC04290572; https://classic.clinicaltrials.gov/.

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两剂量口服异维甲酸治疗顽固性面部扁平疣的双盲随机研究：对生活质量、焦虑和抑郁的影响

背景和目的顽固性面部扁平疣是由人乳头瘤病毒引起的，尽管治疗，但可能持续数年。口服异维甲酸0.5 mg/kg/天的剂量是有效和安全的。然而，报告的不良反应是剂量依赖行为，可能会限制其使用。我们的目的是比较两种剂量口服异维甲酸治疗顽固性面部扁平疣的疗效和安全性，并评估被研究个体的生活质量、焦虑和抑郁。方法采用双盲、随机方法，分别给予异维a酸0.3 mg/kg/d和0.5 mg/kg/d治疗21例和19例成人患者，疗程12周。评估皮肤病变，并记录不良事件，包括血清学变化。如果患者接受以下至少两种治疗至少3年：类维生素a、5-氟尿嘧啶、咪喹莫特和冷冻治疗，则认为疣是顽固性的。此外，在随访开始和结束时对生活质量、焦虑和抑郁进行评估。结果异维a酸0.3 mg/kg/day组完全缓解率为35%，部分缓解率为66%，而异维a酸0.5 mg/kg/day组完全缓解率为73.7%，部分缓解率为26.31% （p = 0.015）。最常见的不良事件是口腔炎。异维甲酸0.5 mg/kg/d组天冬氨酸转氨酶升高（p = 0.020），总胆红素升高（p = 0.015）。两组患者的生活质量评分均有改善（p = 0.0001），焦虑评分均有降低（p = 0.00）。结论口服异维甲酸0.5 mg/kg/d治疗成人顽固性面部扁平疣安全有效，复发率低于0.3 mg/kg/d。成人长期使用异维甲酸治疗超过12周可提高总有效率。试验注册：Registry of ClinicalTrials.gov标识符：NTC04290572；https://classic.clinicaltrials.gov/。

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