跳至主要内容
临床试验/NCT03834935
NCT03834935Unknown2 期

Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba: A Randomized Placebo-controlled Trial

St Joseph University, Beirut, Lebanon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

发起方
St Joseph University, Beirut, Lebanon
申办方类型
Other
责任方
Principal Investigator
主要研究者

elio kechichian

Principal investigator, MD

St Joseph University, Beirut, Lebanon

研究点 (1)

Loading locations...

相似试验