Manjhi Mukesh, Yadav Pravesh, Mohan Sneha, Sonthalia Sidharth, Ramesh V, Kashyap Varun
Department of Dermatology, Hamdard Institute of Medical Sciences and Research and HAH Centenary Hospital, New Delhi, India.
Department of Dermatology, Lady Hardinge Medical College and Associated Hospital, New Delhi, India.
Dermatol Ther. 2020 Nov;33(6):e13954. doi: 10.1111/dth.13954. Epub 2020 Jul 27.
The aim of this study was to compare the efficacy and safety of 0.1% triamcinolone acetonide and 0.03% tacrolimus ointment for the treatment of nodular lesions of scabies. In this double-blind randomized controlled trial, 50 Indian men with postscabeitic persistent nodular lesions (labelled to have nodular scabies (NS)/postscabies prurigo (PSP)) over the external genitalia, were enrolled. They were randomized into two groups to receive either a mid-potency topical corticosteroid (TCS); triamcinolone acetonide 0.1% ointment twice daily, or topical calcineurin inhibitor (CNI); tacrolimus ointment 0.03% twice daily over the nodular lesions for 2 weeks. All patients were followed up on three visits: 1, 2, and 6 weeks, for assessment. Efficacy was evaluated by 5-point range investigator-assessed VAS, and a 4-point severity of pruritus scale (SPS) score. The mean VAS score was higher in triamcinolone group compared to tacrolimus group at both follow-ups, although statistically significant only at 2nd week visit. The fall in mean SPS at both follow-ups was also higher in the steroid group, but the difference was not statistically significant. While, the overall tolerance to either ointment was excellent, mild hypopigmentation, and epidermal atrophy were detected on dermoscopic evaluation of the treated areas at the 2nd week visit in a small subset of patients in the triamcinolone group. The frequency of relapse of lesions and/or pruritus after four weeks of the 2-week therapy was high in both the groups (higher in tarolimus group). Conclusively, although both treatment options provided safe and satisfactory short term improvement, the results from this study suggest an overall higher efficacy of a mid-potency TCS like triamcinolone 0.1% over topical CNI like tacrolimus 0.03%, in the short-term treatment of nodular lesions of NS/PSP. Topical CNIs may be considered for maintenance of effect, if prolonged therapy is warranted.
本研究旨在比较0.1%曲安奈德和0.03%他克莫司软膏治疗疥疮结节性皮损的疗效和安全性。在这项双盲随机对照试验中,招募了50名印度男性,他们的外生殖器患有疥疮后持续性结节性皮损(标记为结节性疥疮(NS)/疥疮后痒疹(PSP))。他们被随机分为两组,分别接受中效外用糖皮质激素(TCS);0.1%曲安奈德软膏,每日两次,或外用钙调神经磷酸酶抑制剂(CNI);0.03%他克莫司软膏,每日两次,涂抹于结节性皮损上,持续2周。所有患者在第1、2和6周进行三次随访评估。疗效通过5分制范围的研究者评估视觉模拟量表(VAS)和4分制瘙痒严重程度量表(SPS)评分进行评估。在两次随访中,曲安奈德组的平均VAS评分均高于他克莫司组,尽管仅在第2周随访时具有统计学意义。在两次随访中,类固醇组的平均SPS下降幅度也更高,但差异无统计学意义。虽然两种软膏的总体耐受性都很好,但在第2周随访时,对曲安奈德组一小部分患者的治疗区域进行皮肤镜评估时,发现有轻度色素减退和表皮萎缩。两组在2周治疗4周后皮损和/或瘙痒复发的频率都很高(他克莫司组更高)。总之,虽然两种治疗方案都能提供安全且令人满意的短期改善,但本研究结果表明,在NS/PSP结节性皮损的短期治疗中,0.1%曲安奈德这种中效TCS总体疗效高于0.03%他克莫司这种外用CNI。如果需要长期治疗,可以考虑外用CNIs来维持疗效。