Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba

NCT03834935 | Unknown Phase 2 DMC

• 1 other identifier: USJDERM1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Pityriasis Alba

Keywords

pityriasis alba; treatment; topical calcineurin inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

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.

Drug: Elidel (pimecrolimus 1%)

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.

Drug: Cold Cream

Interventions

Elidel (pimecrolimus 1%) DRUG

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

Pim

Cold Cream DRUG

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

Pl

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Saint Joseph University

Beirut, 166830, Lebanon

Location

MeSH Terms

Conditions

Dandruff

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Scalp Dermatoses

Study Officials

• Josiane Helou, MD

  Saint-Joseph University

  STUDY CHAIR

Central Study Contacts

elio G kechichian, MD

CONTACT

+9613079072; elio.kechichian@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: investigators and patients will be blinded to treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: March 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

LE (1)