Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Psoriasis; Plaque Psoriasis

Treatments: Drug: Enstilar® foam; Drug: Vehicle foam

Study type: Interventional

Funder types: Other

Identifiers

NCT03506477

GCO 17-2468

HSM# 17-05032 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide written, signed and dated informed consent prior to initiating any study-related activities.
• Male or female >18 years of age at the time of screening
• Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited to - --African Americans, Asians, Pacific Islanders and Hispanics.
• Clinical diagnosis of chronic plaque-type psoriasis of the body
• Plaque psoriasis with ≥2% Body Surface Area (BSA) involvement (may include scalp involvement), PASI Score ≥ 2, IGA mod 2011 score of 2 or greater (based on scale of 0-4)
• Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While using investigational product and for at least 28 days after last application of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options d
• Must be in general good health as judged by the Investigator, based on medical history and physical examination.

Exclusion criteria

• Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate, erythrodermic, pustular)
• Diagnosis of other active, ongoing skin diseases or skin infections that may interfere with examination of psoriasis lesions
• Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy. The following washout periods will be required: 2 weeks for topical therapy; 2 weeks for phototherapy; 12 weeks for biologic or targeted therapies; 4 weeks for other systemic therapies
• Use of oral estrogen therapy, excluding oral contraceptive pills
• Women who are pregnant, nursing, or of child-bearing potential who are unwilling to use appropriate method(s) of contraception.
• Patients unwilling to limit exposure to UV light
• Current significant medical problems that, in the discretion of the investigator, would put the patient at significant risk
• Patients with disorders of calcium metabolism and/or hypercalcemia
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
• History of allergy to any component of the IP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Enstilar® foam

Experimental group

Description:

Enstilar® foam - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.

Treatment:

Drug: Enstilar® foam

Vehicle foam

Placebo Comparator group

Description:

does not contain the active ingredient

Treatment:

Drug: Vehicle foam