Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of repigmentation of index lesions
研究概览
简要总结
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. The objective is to evaluate the effect of topical pimecrolimus in the treatment of treatment of PA
详细描述
Background and Rationale:
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. PA usually manifests as erythematous lesions followed by smooth scales with residual characteristic pruritic or non-pruritic ill-defined hypopigmented patches, that typically occur on the upper part of the body, especially the face. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. It is thought to represent nonspecific dermatitis with residual post-inflammatory hypopigmentation. Sun exposure is a triggering and accentuating factor.
PA is a common reason for dermatologic consultation due to its chronic course, frequent relapses and cosmetic appearance. Spontaneous healing occurs in several months to few years, therefore impacting the quality of life. Emollients and mild-potency topical steroids are the mainstay of treatment, with a potential risk of skin atrophy and hypopigmentation.
Pimecrolimus is a topical calcineurin inhibitor that prevents T-cell activation, approved for the treatment of atopic dermatitis, and proved efficacious for seborrheic dermatitis, without having the potential adverse effects of topical corticosteroids. Tacrolimus 0.1% ointment, another calcineurin inhibitor is an effective and safe treatment for PA, a similar efficacy of calcitriol and tacrolimus was shown after 9 weeks of treatment. An exploratory study evaluated the efficacy of pimecrolimus cream in the treatment of PA. To the best of our knowledge there is no randomized placebo-controlled trial in the literature proving the efficacy of pimecrolimus in PA.
Objective: To evaluate the effect of topical pimecrolimus in the treatment of treatment of PA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
investigators and patients will be blinded to treatment
入排标准
- 年龄范围
- 2 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pityriasis alba Patients confirmed by a board certified dermatologist
- •Age over 2 years
- •Written informed consent signed by the patients or the legal guardians of patients younger than 18 years in the native language (Arabic)
排除标准
- •Other concomitant dermatosis (except atopic dermatitis)
- •Use of topical steroids, or topical agents other than emollients and sunscreen, in the last 4 weeks
- •Known allergy to pimecrolimus
- •Pregnant and nursing women
研究组 & 干预措施
Pim
20 patients receiving topical Elidel (pimecrolimus 1%) bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.
干预措施: Elidel (pimecrolimus 1%) (Drug)
Pl
20 patients receiving placebo (control group), cold cream bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.
干预措施: Cold Cream (Drug)
结局指标
主要结局
Percentage of repigmentation of index lesions
时间窗: 9 weeks
Objective percentage of repigmentation the index lesion (the largest lesion) by image analysis software (ImageJ software will be used to measure the lesion reduction area after treatments)
次要结局
- Pruritus and scaling(3,6 and 9 weeks)
- Investigator's repigmentation change(3,6 and 9 weeks)
- patient satisfaction(9 weeks)
- Adverse events(3,6 and 9 weeks)
研究者
elio kechichian
Principal investigator, MD
St Joseph University, Beirut, Lebanon
