Clinical trial NCT03506477: Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
Official title: A Double-blinded, Placebo-controlled Study to Evaluate the Tolerability and Efficacy of Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Psoriasis
Keywords: skin of color
psoriasis
Enstilar
skin diseases
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4:1 Enstilar(R): placebo from baseline to week 4, then open-label Enstilar from weeks 4 to 8.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients Who Achieved Treatment Success
timeFrame: Week 4
Secondary outcomes:
measure: Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI)
timeFrame: 4 weeks, 8 weeks
measure: Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI)
timeFrame: 2 weeks, 4 weeks, 8 weeks
measure: Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011)
timeFrame: at week 8
measure: Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA)
timeFrame: 4 weeks, 8 weeks
measure: Patient's Global Assessment of Itch
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
measure: Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA)
timeFrame: 4 weeks, 8 weeks
measure: Erythema Indices of Target Psoriasis Plaque
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
measure: Melanin Indices of Target Psoriasis Plaque
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
measure: Physician Dyspigmentation Visual Analog Scale (VAS)
timeFrame: baseline, 4 weeks, 8 weeks
measure: Mean Change in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrew Alexis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: