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| ID | Type | Description | Link |
|---|---|---|---|
| HSM# 17-05032 | Other Identifier | Icahn School of Medicine at Mount Sinai |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enstilar® foam | Experimental | Enstilar® foam - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%. |
|
| Vehicle foam | Placebo Comparator | does not contain the active ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enstilar® foam | Drug | for 4 weeks |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 weeks, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Alexis, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | New York | New York | 10023 | United States |
With Leo, Pharma.
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Patients were recruited from the dermatology faculty practice and resident clinics in the Mount Sinai Health System from May 2018 through July 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Enstilar® Foam | Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%. |
| FG001 | Vehicle Foam | Vehicle foam: for 4 weeks - does not contain the active ingredient |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enstilar® Foam | Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%. |
| BG001 | Vehicle Foam | Vehicle foam: for 4 weeks - does not contain the active ingredient |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Week 4 |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enstilar® Foam | Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common Cold | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ingrid Sanabria-Gonzalez | Icahn School of Medicine at Mount Sinai | 212-523-3812 | ingrid.sanabria@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2017 | Sep 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 10, 2017 | Sep 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
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4:1 Enstilar(R): placebo from baseline to week 4, then open-label Enstilar from weeks 4 to 8.
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Double-blind, vehicle-controlled from week 0 to 4
| Vehicle foam | Drug | for 4 weeks |
|
| 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). | 2 weeks, 4 weeks, 8 weeks |
| 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. | at week 8 |
| 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. | 4 weeks, 8 weeks |
| 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). | Baseline, 2 weeks, 4 weeks, 8 weeks |
| 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. | 4 weeks, 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. | Baseline, 2 weeks, 4 weeks, 8 weeks |
| 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. | Baseline, 2 weeks, 4 weeks, 8 weeks |
| 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). | baseline, 4 weeks, 8 weeks |
| 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. | Baseline, 2 weeks, 4 weeks, 8 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| IGA mod 2011 | Investigator's Global Assessment (2011 modified version ) (IGA mod 2011) is a five-category scale indicating the physician's overall assessment of psoriasis severity, by induration, erythema, and scaling, evaluated with categories of "0 = clear," "1 = almost clear," "2 = mild," "3 = moderate," or "4 = severe." | Mean | Standard Deviation | units on a scale |
|
| Scalp Investigator Global Assessment (ScIGA) | ScIGA ranges from 0 (clear) to 4 (severe). | Data only for those participants with scalp disease at baseline | Mean | Standard Deviation | units on a scale |
|
| Patient's Global Assessment of disease severity (PaGA) | PaGA have 5 distinct options ranging from (0) "Clear" to (4) "Severe." | Mean | Standard Deviation | units on a scale |
|
|
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| Secondary | 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) | Posted | Count of Participants | Participants | 4 weeks, 8 weeks |
|
|
|
| Secondary | 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). | Variation in N due to # of patients who completed study visits at each timepoint. | Posted | Count of Participants | Participants | 2 weeks, 4 weeks, 8 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | at week 8 |
|
|
|
| Secondary | 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. | Data for participants with scalp disease who completed the respective study visits. | Posted | Count of Participants | Participants | 4 weeks, 8 weeks |
|
|
|
| Secondary | 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). | data only for participants who completed respective study visits | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 4 weeks, 8 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 4 weeks, 8 weeks |
|
|
|
| Secondary | 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. | data results for participants who completed respective study visits | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks, 8 weeks |
|
|
|
| Secondary | 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. | data results for participants who completed respective study visits | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks, 8 weeks |
|
|
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks, 8 weeks |
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| Secondary | 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. | data results for participants who completed respective study visits | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 4 weeks, 8 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | Vehicle Foam | Vehicle foam: for 4 weeks - does not contain the active ingredient | 0 | 5 | 0 | 5 | 1 | 5 |
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Bee Sting | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Upper Extremity Pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Headache | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Seasonal Allergies | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Seborrheic Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Worsening Intertrigo | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Daytime Sleepiness | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Hypopigmented Macules | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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