PDF(Pubmed)
Abstract：
BACKGROUND: Treatment of early-stage mycosis fungoides (MF) requires safe, skin-directed therapies. Medication side effects can lead to underutilization of effective therapies. The objective of this study was to assess the use of topical triamcinolone 0.1% ointment as a means of reducing contact dermatitis associated with topical mechlorethamine/chlormethine gel for the treatment of MF.
METHODS: This prospective, randomized, open-label study evaluated 28 adults with mycosis fungoides who were eligible for treatment with topical mechlorethamine/chlormethine gel from December 17, 2017 to December 23, 2020. Patients were treated for 4 months with clinical follow-up through 12 months. Patients had half of their lesions also treated with topical triamcinolone 0.1% ointment (while the other half were treated with mechlorethamine/chlormethine alone). The study was self-controlled with separate lesions in the same patient receiving each treatment arm. Treatment arms were determined by the flip of a coin.
RESULTS: Twenty-eight patients enrolled (17 men (61%) and 11 women (39%)). Demographics included 25 White, 2 African Americans, and 1 Asian patient. Twenty-five completed the 12-month follow-up. Triamcinolone 0.1% ointment led to increased tolerability of mechlorethamine/chlormethine gel but did not change the efficacy of mechlorethamine/chlormethine. There was a statistically significant 50% decrease in dermatitis (SCORD score) at month 2 in the triamcinolone-treated arm.
CONCLUSIONS: Topical triamcinolone ointment is a helpful adjuvant therapy when treating patients with topical mechlorethamine/chlormethine gel. It diminishes inflammation and does not reduce efficacy. The peak incidence of dermatitis in the study occurred in the second and third months.
BACKGROUND: ClinicalTrials.gov identifier, NCT03380026.
METHODS: This prospective, randomized, open-label study evaluated 28 adults with mycosis fungoides who were eligible for treatment with topical mechlorethamine/chlormethine gel from December 17, 2017 to December 23, 2020. Patients were treated for 4 months with clinical follow-up through 12 months. Patients had half of their lesions also treated with topical triamcinolone 0.1% ointment (while the other half were treated with mechlorethamine/chlormethine alone). The study was self-controlled with separate lesions in the same patient receiving each treatment arm. Treatment arms were determined by the flip of a coin.
RESULTS: Twenty-eight patients enrolled (17 men (61%) and 11 women (39%)). Demographics included 25 White, 2 African Americans, and 1 Asian patient. Twenty-five completed the 12-month follow-up. Triamcinolone 0.1% ointment led to increased tolerability of mechlorethamine/chlormethine gel but did not change the efficacy of mechlorethamine/chlormethine. There was a statistically significant 50% decrease in dermatitis (SCORD score) at month 2 in the triamcinolone-treated arm.
CONCLUSIONS: Topical triamcinolone ointment is a helpful adjuvant therapy when treating patients with topical mechlorethamine/chlormethine gel. It diminishes inflammation and does not reduce efficacy. The peak incidence of dermatitis in the study occurred in the second and third months.
BACKGROUND: ClinicalTrials.gov identifier, NCT03380026.
摘要：
背景：治疗早期真菌病（MF）需要安全，皮肤导向疗法。药物副作用可导致有效疗法的利用不足。这项研究的目的是评估使用0.1％的局部曲安奈德软膏作为减少与局部甲胺/氯甲芬凝胶治疗MF相关的接触性皮炎的方法。
方法：这种前瞻性，随机化，开放标签研究评估了2017年12月17日至2020年12月23日符合接受局部用甲氯胺/氯甲芬凝胶治疗条件的28例支原体病成人.患者治疗4个月，临床随访12个月。患者的一半病变也用0.1％的局部曲安奈德软膏治疗（而另一半仅用甲胺/氯甲芬治疗）。该研究是在接受每个治疗组的同一患者中使用单独的病变进行自我控制。通过掷硬币确定治疗臂。
结果：28名患者（17名男性（61%）和11名女性（39%））。人口统计包括25个白人，2非洲裔美国人,1名亚洲患者。25人完成了为期12个月的随访。0.1％曲安奈德软膏可提高甲胺/氯甲芬凝胶的耐受性，但未改变甲胺/氯甲芬的功效。在第2个月时，曲安奈德治疗的手臂中，皮炎（SCORD评分）的统计学显着降低了50％。
结论：当局部用甲胺/氯甲芬凝胶治疗患者时，局部用曲安奈德软膏是一种有用的辅助治疗。它减少炎症并且不降低功效。研究中皮炎的高峰发生率发生在第二个和第三个月。
背景：ClinicalTrials.gov标识符，NCT03380026。
方法：这种前瞻性，随机化，开放标签研究评估了2017年12月17日至2020年12月23日符合接受局部用甲氯胺/氯甲芬凝胶治疗条件的28例支原体病成人.患者治疗4个月，临床随访12个月。患者的一半病变也用0.1％的局部曲安奈德软膏治疗（而另一半仅用甲胺/氯甲芬治疗）。该研究是在接受每个治疗组的同一患者中使用单独的病变进行自我控制。通过掷硬币确定治疗臂。
结果：28名患者（17名男性（61%）和11名女性（39%））。人口统计包括25个白人，2非洲裔美国人,1名亚洲患者。25人完成了为期12个月的随访。0.1％曲安奈德软膏可提高甲胺/氯甲芬凝胶的耐受性，但未改变甲胺/氯甲芬的功效。在第2个月时，曲安奈德治疗的手臂中，皮炎（SCORD评分）的统计学显着降低了50％。
结论：当局部用甲胺/氯甲芬凝胶治疗患者时，局部用曲安奈德软膏是一种有用的辅助治疗。它减少炎症并且不降低功效。研究中皮炎的高峰发生率发生在第二个和第三个月。
背景：ClinicalTrials.gov标识符，NCT03380026。
