Liu Jacqueline, Cices Ahuva, Kaufman Bridget, Sanabria-Gonzalez Ingrid, Alexis Andrew
J Drugs Dermatol. 2023 Feb 1;22(2):165-173. doi: 10.36849/JDD.6910.
There is a paucity of data on usage of topical medications in patients with darker phototypes. This single-center, randomized, double-blinded, vehicle-controlled clinical study investigated the efficacy of a combination calcipotriene/betamethasone dipropionate (Cal/BD) aerosol foam 0.005%/0.064% in the treatment of psoriasis vulgaris in Fitzpatrick skin types IV to VI.
25 adult subjects were randomized 4:1 to Cal/BD foam or foam vehicle once daily for 4 weeks followed by 4 weeks of open label treatment. From week 4 to week 8, subjects randomized to Cal/BD foam once daily switched to Cal/BD foam twice weekly for 4 weeks, while those randomized to vehicle applied Cal/BD foam once daily.
At week 4, 4/19 (21%) of Cal/BD foam patients achieved clear/almost clear Investigator Global Assessment (IGA) status with ≥2 grade improvement compared with 0/5 (0%) of vehicle patients (P=0.54). 12/19 (63%) of Cal/BD foam patients achieved a 50% reduction in Psoriasis Area and Severity Index (PASI 50) at week 4, compared with 0/5 (0%) of vehicle patients (P=0.04). Mean changes in melanin index at week 4 indicate a trend toward increased pigmentation in Cal/BD foam patients and decreased pigmentation in foam vehicle patients (P=0.30). All adverse events were mild and deemed unrelated to treatment by the investigators.
The sample size was small and underpowered to detect statistically significant changes in most endpoints.
Cal/BD foam was safe and well tolerated in plaque psoriasis patients with skin of color. Larger studies involving skin of color populations with psoriasis are warranted. Pigmentary changes (hyper- and hypopigmentation) in lesional skin were observed. J Drugs Dermatol. 2023;22(2): 165-173.doi:10.36849/JDD.6910.
关于深肤色患者局部用药的数据匮乏。这项单中心、随机、双盲、赋形剂对照的临床研究调查了0.005%/0.064%的卡泊三醇/倍他米松二丙酸酯（Cal/BD）气雾剂泡沫治疗IV至VI型菲茨帕特里克皮肤类型寻常型银屑病的疗效。
25名成年受试者按4:1随机分为Cal/BD泡沫组或赋形剂泡沫组，每天一次，持续4周，随后进行4周的开放标签治疗。从第4周到第8周，随机分配至每天一次Cal/BD泡沫组的受试者改为每周两次Cal/BD泡沫，持续4周，而随机分配至赋形剂组者每天使用一次Cal/BD泡沫。
第4周时，19名Cal/BD泡沫组患者中有4名（21%）达到清除/几乎清除的研究者整体评估（IGA）状态，改善程度≥2级，而赋形剂组5名患者中无1名（0%）达到此状态（P = 0.54）。第4周时，19名Cal/BD泡沫组患者中有12名（63%）实现银屑病面积和严重程度指数（PASI 50）降低50%，而赋形剂组5名患者中无1名（0%）达到此状态（P = 0.04）。第4周时黑色素指数的平均变化表明，Cal/BD泡沫组患者有色素沉着增加的趋势，赋形剂泡沫组患者有色素沉着减少的趋势（P = 0.30）。所有不良事件均为轻度，研究者认为与治疗无关。
样本量小，不足以检测大多数终点的统计学显著变化。
Cal/BD泡沫对有色素沉着皮肤的斑块状银屑病患者安全且耐受性良好。有必要开展涉及有色素沉着皮肤的银屑病患者群体的更大规模研究。观察到皮损处有色素变化（色素沉着过多和色素沉着过少）。《药物皮肤病学杂志》。2023年；22(2): 165 - 173。doi:10.36849/JDD.6910。
