Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba

NCT ID: NCT03834935

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-04-01

Brief Summary

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

Detailed Description

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

Hypothesis: Pimecrolimus is an efficacious, well-tolerated and safe treatment for pityriasis alba.

Trial design: A randomized placebo-controlled double blinded trial establishing the superiority of topical pimecrolimus 1% over placebo.

Conditions

Pityriasis Alba

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Elidel (pimecrolimus 1%)

Intervention Type: DRUG

topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed

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.

Group Type: PLACEBO_COMPARATOR

Cold Cream

Intervention Type: DRUG

Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed

Interventions

Elidel (pimecrolimus 1%)

topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed

Intervention Type: DRUG

Cold Cream

Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Joseph University, Beirut, Lebanon

OTHER

Sponsor Role: lead

Responsible Party

elio kechichian

Principal investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josiane Helou, MD

Role: STUDY_CHAIR

Saint-Joseph University

Locations

Saint Joseph University

Beirut, , Lebanon

Countries

Lebanon

Central Contacts

elio G kechichian, MD

Role: CONTACT

elio.kechichian@gmail.com

+9613079072

Facility Contacts

elio kechichian

Role: primary

elio.kechichian@gmail.com

3079072

Other Identifiers

USJDERM1

Identifier Type: -

Identifier Source: org_study_id