Pityriasis Alba Clinical Trial
Official title:
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
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03443765 -
Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
|
||
| Completed |
NCT01388517 -
Clinical Trial of 0.0003% Calcitriol, 0.1% Tacrolimus, and Petrolatum for the Treatment of Pityriasis Alba
|
Phase 4 |