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Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834935
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
elio kechichian, St Joseph University, Beirut, Lebanon

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

Condition or disease Intervention/treatment Phase
Pityriasis Alba Drug: Elidel (pimecrolimus 1%) Drug: Cold Cream Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: investigators and patients will be blinded to treatment
Primary Purpose: Treatment
Official Title: Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba: A Randomized Placebo-controlled Trial
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percentage of repigmentation of index lesions [ Time Frame: 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)


Secondary Outcome Measures :
  1. Pruritus and scaling [ Time Frame: 3,6 and 9 weeks ]
    IGA 4 point-scale (0: none - 3: severe)

  2. Investigator's repigmentation change [ Time Frame: 3,6 and 9 weeks ]
    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. patient satisfaction [ Time Frame: 9 weeks ]
    (0: not satisfied, 1: satisfied, 2: very satisfied).

  4. Adverse events [ Time Frame: 3,6 and 9 weeks ]
    adverse events reporting



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834935


Contacts
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Contact: elio G kechichian, MD +9613079072 elio.kechichian@gmail.com

Locations
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Lebanon
Saint Joseph University
Beirut, Lebanon, 166830
Contact: elio kechichian    3079072    elio.kechichian@gmail.com   
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon
Investigators
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Study Chair: Josiane Helou, MD Saint-Joseph University
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Responsible Party: elio kechichian, Principal investigator, MD, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier: NCT03834935    
Other Study ID Numbers: USJDERM1
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by elio kechichian, St Joseph University, Beirut, Lebanon:
pityriasis alba
treatment
topical calcineurin inhibitor
Additional relevant MeSH terms:
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Pityriasis
Pityriasis Rosea
Dandruff
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Scalp Dermatoses
Pimecrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action