Back to resultsEnstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
Primary Purpose
Plaque Psoriasis, Psoriasis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enstilar® foam
Vehicle foam
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring skin of color, psoriasis, Enstilar, skin diseases
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
Sites / Locations
- Mount Sinai West
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Enstilar® foam
Vehicle foam
Arm Description
Enstilar® foam - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.
does not contain the active ingredient
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI)
Number of patients achieving ≥50% improvement and/or ≥75% improvement in PASI at weeks 4 and 8 . PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease)
Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI)
Number of patients achieving ≥50% improvement and/or ≥75% improvement in PSSI at weeks 2, 4 and 8. The Psoriasis Scalp Severity Index (PSSI) assesses severity of scalp disease along the parameters of erythema, induration, and desquamation. The PSSI uses a 5-point scale to grade the three aforementioned clinical parameters. The parameters scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The PSSI score ranges from 0 (no disease) to 72 (maximal disease).
Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011)
Number of patients at week 8 who achieved treatment success according to 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.
Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA)
Number of patients at weeks 4 and 8 who achieved treatment success according to ScIGA. ScIGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as ScIGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or ScIGA of clear (0) for patients with mild disease at baseline.
Patient's Global Assessment of Itch
Patient's Global Assessment of Itch as compared to baseline measured by Visual Analog Scale (VAS). The VAS is a numerical scale used to assess patients' perception of pruritus/itch.The evaluation is a 10cm long line on which the subjects indicate the severity of their pruritus from "0" (no pruritus) to "10" (severe pruritus).
Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA)
PaGA have 5 distinct options ranging from (0) "Clear" to (4) "Severe." Number of participants with treatment response defined as clear or almost clear disease (for those with moderate or severe disease at baseline) or clear disease (for those with mild disease at baseline) at 4 weeks and 8 weeks.
Erythema Indices of Target Psoriasis Plaque
A skin spectrophotometer (Mexameter) was used to quantify the degree of erythema of lesional skin compared to an index area (of unaffected skin). The mexameter measures from 0-999. The higher the value for erythema index the more red pigmentation in the skin, this is assessed by quantification of hemoglobin in the skin via reflectance spectroscopy.
Melanin Indices of Target Psoriasis Plaque
A skin spectrophotometer (Mexameter) was used to quantify the melanin index (degree of hyperpigmentation or hypopigmentation) of lesional skin compared to an index area of unaffected skin. The mexameter measures from 0-999. The higher the value for melanin index, the more brown pigment in the skin, this is assessed by quantification of melanin in the skin via reflectance spectroscopy.
Physician Dyspigmentation Visual Analog Scale (VAS)
An investigator performed a visual analog scale (VAS) rating the degree of dyspigmentation of the skin. This VAS ranges from - 5 to 5 as follows: 5 severe dark brown pigmentation (darkest imaginable color), 4 dark brown pigmentation, 3 medium brown pigmentation, 2 light brown pigmentation, 1 slight dark pigmentation (barely perceptible compared to surrounding skin), 0 baseline skin pigmentation, -1 slight hypopigmentation (barely perceptible compared to surrounding skin), -2 mild hypopigmentation (light brown), -3 moderate hypopigmentation (creme-colored skin), -4 severe hypopigmentation (almost complete absence of pigment), -5 depigmentation (complete absence of pigment).
Mean Change in Dermatology Life Quality Index (DLQI)
DLQI full scale ranges from 0 (no effect at all on patient's life) to 30 (extremely large effect on patients' life). Mean change from Baseline in DLQI at 2, 4, and 8 weeks.
Full Information
NCT ID
NCT03506477
First Posted
April 17, 2018
Last Updated
December 29, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT03506477
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis, Psoriasis
Keywords
skin of color, psoriasis, Enstilar, skin diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
4:1 Enstilar(R): placebo from baseline to week 4, then open-label Enstilar from weeks 4 to 8.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind, vehicle-controlled from week 0 to 4
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enstilar® foam
Arm Type
Experimental
Arm Description
Enstilar® foam - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.
Arm Title
Vehicle foam
Arm Type
Placebo Comparator
Arm Description
does not contain the active ingredient
Intervention Type
Drug
Intervention Name(s)
Enstilar® foam
Other Intervention Name(s)
Enstilar 0.005%-0.064% Topical Foam
Intervention Description
for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle foam
Intervention Description
for 4 weeks
Primary Outcome Measure Information:
Title
Number of Patients Who Achieved Treatment Success
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI)
Description
Number of patients achieving ≥50% improvement and/or ≥75% improvement in PASI at weeks 4 and 8 . PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease)
Time Frame
4 weeks, 8 weeks
Title
Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI)
Description
Number of patients achieving ≥50% improvement and/or ≥75% improvement in PSSI at weeks 2, 4 and 8. The Psoriasis Scalp Severity Index (PSSI) assesses severity of scalp disease along the parameters of erythema, induration, and desquamation. The PSSI uses a 5-point scale to grade the three aforementioned clinical parameters. The parameters scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The PSSI score ranges from 0 (no disease) to 72 (maximal disease).
Time Frame
2 weeks, 4 weeks, 8 weeks
Title
Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011)
Description
Number of patients at week 8 who achieved treatment success according to 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.
Time Frame
at week 8
Title
Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA)
Description
Number of patients at weeks 4 and 8 who achieved treatment success according to ScIGA. ScIGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as ScIGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or ScIGA of clear (0) for patients with mild disease at baseline.
Time Frame
4 weeks, 8 weeks
Title
Patient's Global Assessment of Itch
Description
Patient's Global Assessment of Itch as compared to baseline measured by Visual Analog Scale (VAS). The VAS is a numerical scale used to assess patients' perception of pruritus/itch.The evaluation is a 10cm long line on which the subjects indicate the severity of their pruritus from "0" (no pruritus) to "10" (severe pruritus).
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks
Title
Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA)
Description
PaGA have 5 distinct options ranging from (0) "Clear" to (4) "Severe." Number of participants with treatment response defined as clear or almost clear disease (for those with moderate or severe disease at baseline) or clear disease (for those with mild disease at baseline) at 4 weeks and 8 weeks.
Time Frame
4 weeks, 8 weeks
Title
Erythema Indices of Target Psoriasis Plaque
Description
A skin spectrophotometer (Mexameter) was used to quantify the degree of erythema of lesional skin compared to an index area (of unaffected skin). The mexameter measures from 0-999. The higher the value for erythema index the more red pigmentation in the skin, this is assessed by quantification of hemoglobin in the skin via reflectance spectroscopy.
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks
Title
Melanin Indices of Target Psoriasis Plaque
Description
A skin spectrophotometer (Mexameter) was used to quantify the melanin index (degree of hyperpigmentation or hypopigmentation) of lesional skin compared to an index area of unaffected skin. The mexameter measures from 0-999. The higher the value for melanin index, the more brown pigment in the skin, this is assessed by quantification of melanin in the skin via reflectance spectroscopy.
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks
Title
Physician Dyspigmentation Visual Analog Scale (VAS)
Description
An investigator performed a visual analog scale (VAS) rating the degree of dyspigmentation of the skin. This VAS ranges from - 5 to 5 as follows: 5 severe dark brown pigmentation (darkest imaginable color), 4 dark brown pigmentation, 3 medium brown pigmentation, 2 light brown pigmentation, 1 slight dark pigmentation (barely perceptible compared to surrounding skin), 0 baseline skin pigmentation, -1 slight hypopigmentation (barely perceptible compared to surrounding skin), -2 mild hypopigmentation (light brown), -3 moderate hypopigmentation (creme-colored skin), -4 severe hypopigmentation (almost complete absence of pigment), -5 depigmentation (complete absence of pigment).
Time Frame
baseline, 4 weeks, 8 weeks
Title
Mean Change in Dermatology Life Quality Index (DLQI)
Description
DLQI full scale ranges from 0 (no effect at all on patient's life) to 30 (extremely large effect on patients' life). Mean change from Baseline in DLQI at 2, 4, and 8 weeks.
Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Alexis, MD, MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
With Leo, Pharma.
Learn more about this trial
Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
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