Rigopoulos D, Gregoriou S, Charissi C, Kontochristopoulos G, Kalogeromitros D, Georgala S
Department of Dermatology, Andreas Sygros Hospital, University of Athens, 5 Ionos Dragoumi Str, 16121 Athens, Greece.
Br J Dermatol. 2006 Jul;155(1):152-5. doi: 10.1111/j.1365-2133.2006.07181.x.
Pityriasis alba (PA) is a frequent reason for dermatological consultation because of its chronic course, tendency to relapse and aesthetic impact.
In view of its strong association with atopic dermatitis, the objective of this open-label study was to assess the efficacy and safety of tacrolimus ointment in the treatment of PA compared with the efficacy of moisturizers.
PATIENTS/METHODS: The study population consisted of 60 individuals of phototype III or IV according to Fitzpatrick's classification, aged 6-21 years. Patients were randomly assigned to one of two groups. Subjects in group A were instructed to apply tacrolimus ointment 0.1% twice daily, 12 h apart, on all hypopigmented macules. Standard moisturizers with SPF 20 sunscreen were used on all lesions applied at least 30 min apart from the tacrolimus ointment. Subjects in group B used solely the same moisturizers with sunscreen. Hypopigmented areas were evaluated at baseline and weeks 0, 3, 6 and 9 by investigators for scaling, hypopigmentation and pruritus on a scale of 0-3. Patient satisfaction was also recorded on a scale of 0-3. All adverse effects were recorded.
A statistically significant improvement through time, in hypopigmentation, pruritus and scaling was observed in both groups during the course of 9 weeks. Hypopigmentation resolved from a baseline score of 2.38+/-0.64 to 1.15+/-0.54 at week 3, 0.46+/-0.51 at week 6 and 0.00+/-0.00 at week 9 for the group applying tacrolimus ointment 0.1%. The difference in improvement between the two groups was statistically significant on all three assessments for hypopigmentation (P<0.001), and for pruritus on week 6 and 9 assessments (P<0.05). Three patients (11.5%) in the tacrolimus group reported a mild transient sensation of burning. All patients in the tacrolimus group reported they were completely satisfied or just satisfied with the treatment compared with only 50% of patients using the placebo.
Tacrolimus ointment 0.1% appears to be an effective and safe treatment for PA.
白色糠疹(PA)因其病程慢性、易复发及对美观有影响,是皮肤科会诊的常见原因。
鉴于其与特应性皮炎密切相关,本开放标签研究的目的是评估他克莫司软膏治疗PA的疗效和安全性,并与保湿剂的疗效进行比较。
患者/方法:研究人群包括60名根据菲茨帕特里克分类法属于III型或IV型皮肤类型、年龄在6至21岁之间的个体。患者被随机分为两组。A组受试者被指示每天两次、间隔12小时在所有色素减退斑上涂抹0.1%他克莫司软膏。在所有皮损上使用含SPF 20防晒剂的标准保湿剂,与他克莫司软膏间隔至少30分钟涂抹。B组受试者仅使用相同的含防晒剂的保湿剂。研究者在基线、第0、3、6和9周对色素减退区域的脱屑、色素减退和瘙痒情况进行0至3级评估。患者满意度也采用0至3级记录。记录所有不良反应。
在9周的疗程中,两组的色素减退、瘙痒和脱屑情况均随时间有统计学显著改善。对于涂抹0.1%他克莫司软膏的组,色素减退从基线评分2.38±0.64在第3周降至1.15±0.54,第6周降至0.46±0.51,第9周降至0.00±0.00。两组在色素减退的所有三项评估中改善情况的差异有统计学意义(P<0.001),在第6周和第9周瘙痒评估中差异有统计学意义(P<0.05)。他克莫司组有3名患者(11.5%)报告有轻微短暂的烧灼感。他克莫司组所有患者报告对治疗完全满意或只是满意,而使用安慰剂的患者中只有50%如此。
0.1%他克莫司软膏似乎是治疗PA的一种有效且安全的方法。