Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba
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|ClinicalTrials.gov Identifier: NCT03834935|
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pityriasis Alba||Drug: Elidel (pimecrolimus 1%) Drug: Cold Cream||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||investigators and patients will be blinded to 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|
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
- 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)
- Pruritus and scaling [ Time Frame: 3,6 and 9 weeks ]IGA 4 point-scale (0: none - 3: severe)
- 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%).
- patient satisfaction [ Time Frame: 9 weeks ](0: not satisfied, 1: satisfied, 2: very satisfied).
- Adverse events [ Time Frame: 3,6 and 9 weeks ]adverse events reporting
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
|Contact: elio G kechichian, MDfirstname.lastname@example.org|
|Saint Joseph University|
|Beirut, Lebanon, 166830|
|Contact: elio kechichian 3079072 email@example.com|
|Study Chair:||Josiane Helou, MD||Saint-Joseph University|