Phase 4
N=25
Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
Plaque Psoriasis · Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03506477 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Patients Who Achieved Treatment Success — 4; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Enstilar® foam (Drug); Vehicle foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Achieved Treatment Success |
4; 0 | — |
| SECONDARY Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI) |
12; 0; 11; 1 | — |
| SECONDARY Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI) |
7; 1; 8; 1; 9; 2 | — |
| SECONDARY Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011) |
3; 0 | — |
| SECONDARY Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA) |
6; 0; 2; 1 | — |
| SECONDARY Patient's Global Assessment of Itch |
6.9; 6.4; 3.6; 1.3; 3.1; 3.2 | — |
| SECONDARY Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA) |
6; 1; 6; 1 | — |
| SECONDARY Erythema Indices of Target Psoriasis Plaque |
563.1; 559.8; 14.7; 22.3; 13.2; 10.4 | — |
| SECONDARY Melanin Indices of Target Psoriasis Plaque |
578.8; 611; 14.0; -12.0; 14.5; -11.8 | — |
| SECONDARY Physician Dyspigmentation Visual Analog Scale (VAS) |
1.26; 2; -0.4; 0.2; -0.5; -0.4 | — |
| SECONDARY Mean Change in Dermatology Life Quality Index (DLQI) |
11.9; 14.4; -4.4; -11.3; -6.5; -6.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03506477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.