Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba

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

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

Study Overview

• Status: Unknown
• Conditions: Pityriasis Alba
• Intervention / Treatment: Drug: Elidel (pimecrolimus 1%); Drug: Cold Cream

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: elio G kechichian, MD; Phone Number: +9613079072; Email: elio.kechichian@gmail.com

Study Locations

• Lebanon
  • Beirut, Lebanon, 166830
    • Saint Joseph University
    • Contact: elio kechichian; Phone Number: 3079072; Email: elio.kechichian@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Placebo Comparator: 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.	Drug: Cold Cream; Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus and scaling	IGA 4 point-scale (0: none - 3: severe)	3,6 and 9 weeks
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
patient satisfaction	(0: not satisfied, 1: satisfied, 2: very satisfied).	9 weeks
Adverse events	adverse events reporting	3,6 and 9 weeks

Collaborators and Investigators

• Sponsor: St Joseph University, Beirut, Lebanon
• Investigators: Study Chair: Josiane Helou, MD, Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: treatment; pityriasis alba; topical calcineurin inhibitor
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Dermatitis; Scalp Dermatoses; Dandruff; Pityriasis; Pityriasis Rosea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Calcineurin Inhibitors; Pimecrolimus
• Other Study ID Numbers: USJDERM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No