Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba

Pityriasis Alba Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03834935
• Other study ID #: USJDERM1
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: March 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2019
• Source: St Joseph University, Beirut, Lebanon
• Contact: elio G kechichian, MD
• Phone: +9613079072
• Email: elio.kechichian[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dandruff
• Pityriasis Alba

Intervention

Drug:
• Elidel (pimecrolimus 1%)
topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
• Cold Cream
Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed

Locations

Country	Name	City	State
Lebanon	Saint Joseph University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of repigmentation of index lesions	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)	9 weeks
Secondary	Pruritus and scaling	IGA 4 point-scale (0: none - 3: severe)	3,6 and 9 weeks
Secondary	Investigator's repigmentation change	Clinical change is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%).	3,6 and 9 weeks
Secondary	patient satisfaction	(0: not satisfied, 1: satisfied, 2: very satisfied).	9 weeks
Secondary	Adverse events	adverse events reporting	3,6 and 9 weeks