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

NCT ID: NCT03506477

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2019-09-25

Brief Summary

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.

Detailed 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.

Conditions

Plaque Psoriasis; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Enstilar® foam

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

Group Type: EXPERIMENTAL

Enstilar® foam

Intervention Type: DRUG

for 4 weeks

Vehicle foam

does not contain the active ingredient

Group Type: PLACEBO_COMPARATOR

Vehicle foam

Intervention Type: DRUG

for 4 weeks

Interventions

Enstilar® foam

for 4 weeks

Intervention Type: DRUG

Vehicle foam

for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Enstilar 0.005%-0.064% Topical Foam

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Andrew Alexis, MD

Chair, Department of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Alexis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai West

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HSM# 17-05032

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 17-2468

Identifier Type: -

Identifier Source: org_study_id