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

NCT03506477 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GCO 17-2468HSM# 17-05032
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis; Psoriasis

Keywords

skin of color; psoriasis; Enstilar; skin diseases

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Achieved Treatment Success

  Number of patients at week 4 who achieved treatment success according to Investigator's Global Assessment (IGA mod 2011) of the entire body including scalp. IGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as IGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or IGA of clear (0) for patients with mild disease at baseline.

  Week 4

Secondary Outcomes (10)

• Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI)

  4 weeks, 8 weeks

• Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI)

  2 weeks, 4 weeks, 8 weeks

• Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011)

  at week 8

• Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA)

  4 weeks, 8 weeks

• Patient's Global Assessment of Itch

  Baseline, 2 weeks, 4 weeks, 8 weeks

Study Arms (2)

Enstilar® foam

EXPERIMENTAL

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

Drug: Enstilar® foam

Vehicle foam

PLACEBO COMPARATOR

does not contain the active ingredient

Drug: Vehicle foam

Interventions

Enstilar® foam DRUG

for 4 weeks

Also known as: Enstilar 0.005%-0.064% Topical Foam

Enstilar® foam

Vehicle foam DRUG

for 4 weeks

Vehicle foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

betamethasone dipropionate, calcipotriol drug combination

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Ingrid Sanabria-Gonzalez
• Organization: Icahn School of Medicine at Mount Sinai

ingrid.sanabria@mountsinai.org

212-523-3812

Study Officials

• Andrew Alexis, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, vehicle-controlled from week 0 to 4
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Dermatology

Model Details: 4:1 Enstilar(R): placebo from baseline to week 4, then open-label Enstilar from weeks 4 to 8.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 24, 2018
• Study Start: May 21, 2018
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: January 20, 2021
• Results First Posted: January 20, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)