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This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in skin of color (and its change with Enstilar ® treatment) as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life.
Full description
Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints. This condition occurs in different ethnic groups worldwide with varying prevalence.
There are notable differences in psoriasis presentation in skin of color groups. Black patients with psoriasis tend to have less erythema, increased risk of pigmentation, thicker plaques, more scaling, and greater body involvement as compared to white patients. The resolution of psoriasis lesions in darker skin types is associated with a higher rate of dyspigmentation (both hyper- and hypo-pigmentation), which may be more bothersome to patients than the psoriasis itself. Further, several studies have shown that psoriasis is associated with greater psychological impact and worse quality of life in non-whites with psoriasis compared to whites.
Unique issues in skin of color populations make studies dedicated to darker skin types essential for the treatment of psoriasis in these populations. This study will evaluate the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in darker skin types. This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life in skin of color.
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25 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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