Trial Outcomes & Findings for Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color (NCT NCT03506477)

NCT ID: NCT03506477

Last Updated: 2021-01-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 25 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2021-01-20

Participant Flow

Patients were recruited from the dermatology faculty practice and resident clinics in the Mount Sinai Health System from May 2018 through July 2019

Participant milestones

Measure	Enstilar® Foam Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam Vehicle foam: for 4 weeks - does not contain the active ingredient
Overall Study STARTED	20	5
Overall Study COMPLETED	19	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Enstilar® Foam Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam Vehicle foam: for 4 weeks - does not contain the active ingredient
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Data only for those participants with scalp disease at baseline

Baseline characteristics by cohort

Measure	Enstilar® Foam n=20 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient	Total n=25 Participants Total of all reporting groups
Age, Continuous	49.6 years STANDARD_DEVIATION 14.8 • n=20 Participants	63.0 years STANDARD_DEVIATION 8.9 • n=5 Participants	50.3 years STANDARD_DEVIATION 13.8 • n=25 Participants
Sex: Female, Male Female	8 Participants n=20 Participants	1 Participants n=5 Participants	9 Participants n=25 Participants
Sex: Female, Male Male	12 Participants n=20 Participants	4 Participants n=5 Participants	16 Participants n=25 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=20 Participants	2 Participants n=5 Participants	9 Participants n=25 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=20 Participants	3 Participants n=5 Participants	16 Participants n=25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=5 Participants	0 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=5 Participants	0 Participants n=25 Participants
Race (NIH/OMB) Asian	2 Participants n=20 Participants	1 Participants n=5 Participants	3 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	1 Participants n=5 Participants	1 Participants n=25 Participants
Race (NIH/OMB) Black or African American	12 Participants n=20 Participants	1 Participants n=5 Participants	13 Participants n=25 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants	0 Participants n=5 Participants	0 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=5 Participants	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=20 Participants	2 Participants n=5 Participants	8 Participants n=25 Participants
IGA mod 2011	2.75 units on a scale STANDARD_DEVIATION 0.54 • n=20 Participants	2.8 units on a scale STANDARD_DEVIATION 0.4 • n=5 Participants	2.76 units on a scale STANDARD_DEVIATION 0.51 • n=25 Participants
Scalp Investigator Global Assessment (ScIGA)	2.25 units on a scale STANDARD_DEVIATION 0.60 • n=12 Participants • Data only for those participants with scalp disease at baseline	2.75 units on a scale STANDARD_DEVIATION 0.83 • n=4 Participants • Data only for those participants with scalp disease at baseline	2.38 units on a scale STANDARD_DEVIATION 0.70 • n=16 Participants • Data only for those participants with scalp disease at baseline
Patient's Global Assessment of disease severity (PaGA)	3 units on a scale STANDARD_DEVIATION 0.8 • n=20 Participants	3.6 units on a scale STANDARD_DEVIATION 0.49 • n=5 Participants	3.16 units on a scale STANDARD_DEVIATION 0.78 • n=25 Participants

PRIMARY outcome

Timeframe: Week 4

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.

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Number of Patients Who Achieved Treatment Success	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks

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)

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI) 4 weeks	12 Participants	0 Participants
Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI) 8 weeks	11 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 weeks, 4 weeks, 8 weeks

Population: Variation in N due to # of patients who completed study visits at each timepoint.

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).

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI) 2 weeks	7 Participants	1 Participants
Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI) 4 weeks	8 Participants	1 Participants
Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI) 8 weeks	9 Participants	2 Participants

SECONDARY outcome

Timeframe: at week 8

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.

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011)	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks

Population: Data for participants with scalp disease who completed the respective study visits.

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.

Outcome measures

Measure	Enstilar® Foam n=11 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=4 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA) 4 weeks	6 Participants	0 Participants
Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA) 8 weeks	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks

Population: data only for participants who completed respective study visits

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).

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Patient's Global Assessment of Itch baseline	6.9 score on a scale Standard Deviation 2.4	6.4 score on a scale Standard Deviation 2.33
Patient's Global Assessment of Itch 2 weeks	3.6 score on a scale Standard Deviation 2.2	1.3 score on a scale Standard Deviation 2.3
Patient's Global Assessment of Itch 4 weeks	3.1 score on a scale Standard Deviation 2.5	3.2 score on a scale Standard Deviation 2.3
Patient's Global Assessment of Itch 8 weeks	2.6 score on a scale Standard Deviation 2.2	2.8 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks

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.

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA) 4 weeks	6 Participants	1 Participants
Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA) 8 weeks	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks

Population: data results for participants who completed respective study visits

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.

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Erythema Indices of Target Psoriasis Plaque baseline	563.1 units on a scale Standard Deviation 39.0	559.8 units on a scale Standard Deviation 19.8
Erythema Indices of Target Psoriasis Plaque 2 weeks	14.7 units on a scale Standard Deviation 25.2	22.3 units on a scale Standard Deviation 28.5
Erythema Indices of Target Psoriasis Plaque 4 weeks	13.2 units on a scale Standard Deviation 35.1	10.4 units on a scale Standard Deviation 16.8
Erythema Indices of Target Psoriasis Plaque 8 weeks	7.7 units on a scale Standard Deviation 26.5	22.4 units on a scale Standard Deviation 23.0

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks

Population: data results for participants who completed respective study visits

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.

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Melanin Indices of Target Psoriasis Plaque baseline	578.8 units on a scale Standard Deviation 78.6	611 units on a scale Standard Deviation 98.3
Melanin Indices of Target Psoriasis Plaque 2 weeks	14.0 units on a scale Standard Deviation 33.6	-12.0 units on a scale Standard Deviation 16.1
Melanin Indices of Target Psoriasis Plaque 4 weeks	14.5 units on a scale Standard Deviation 37.0	-11.8 units on a scale Standard Deviation 43.1
Melanin Indices of Target Psoriasis Plaque 8 weeks	25 units on a scale Standard Deviation 39.9	-2.6 units on a scale Standard Deviation 36.9

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

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).

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Physician Dyspigmentation Visual Analog Scale (VAS) baseline	1.26 score on a scale Standard Deviation 1.74	2 score on a scale Standard Deviation 1.26
Physician Dyspigmentation Visual Analog Scale (VAS) 4 weeks	-0.4 score on a scale Standard Deviation 2.5	0.2 score on a scale Standard Deviation 0.4
Physician Dyspigmentation Visual Analog Scale (VAS) 8 weeks	-0.5 score on a scale Standard Deviation 1.8	-0.4 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks

Population: data results for participants who completed respective study visits

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.

Outcome measures

Measure	Enstilar® Foam n=19 Participants Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 Participants Vehicle foam: for 4 weeks - does not contain the active ingredient
Mean Change in Dermatology Life Quality Index (DLQI) baseline	11.9 score on a scale Standard Deviation 5.9	14.4 score on a scale Standard Deviation 8.7
Mean Change in Dermatology Life Quality Index (DLQI) 2 weeks	-4.4 score on a scale Standard Deviation 5.3	-11.3 score on a scale Standard Deviation 4.7
Mean Change in Dermatology Life Quality Index (DLQI) 4 weeks	-6.5 score on a scale Standard Deviation 3.4	-6.8 score on a scale Standard Deviation 8.7
Mean Change in Dermatology Life Quality Index (DLQI) 8 weeks	-6.4 score on a scale Standard Deviation 5.5	-7.2 score on a scale Standard Deviation 6.6

Adverse Events

Enstilar® Foam

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Vehicle Foam

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enstilar® Foam n=20 participants at risk Enstilar® foam x 4 weeks - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.	Vehicle Foam n=5 participants at risk Vehicle foam: for 4 weeks - does not contain the active ingredient
Respiratory, thoracic and mediastinal disorders Common Cold	15.0% 3/20 • 8 weeks	0.00% 0/5 • 8 weeks
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	10.0% 2/20 • 8 weeks	0.00% 0/5 • 8 weeks
Injury, poisoning and procedural complications Bee Sting	5.0% 1/20 • 8 weeks	0.00% 0/5 • 8 weeks
Gastrointestinal disorders Diarrhea	10.0% 2/20 • 8 weeks	0.00% 0/5 • 8 weeks
Musculoskeletal and connective tissue disorders Upper Extremity Pain	10.0% 2/20 • 8 weeks	0.00% 0/5 • 8 weeks
General disorders Headache	5.0% 1/20 • 8 weeks	0.00% 0/5 • 8 weeks
General disorders Seasonal Allergies	5.0% 1/20 • 8 weeks	0.00% 0/5 • 8 weeks
Skin and subcutaneous tissue disorders Seborrheic Dermatitis	5.0% 1/20 • 8 weeks	0.00% 0/5 • 8 weeks
Skin and subcutaneous tissue disorders Worsening Intertrigo	5.0% 1/20 • 8 weeks	0.00% 0/5 • 8 weeks
General disorders Daytime Sleepiness	5.0% 1/20 • 8 weeks	0.00% 0/5 • 8 weeks
Skin and subcutaneous tissue disorders Hypopigmented Macules	0.00% 0/20 • 8 weeks	20.0% 1/5 • 8 weeks

Additional Information

Ingrid Sanabria-Gonzalez

Icahn School of Medicine at Mount Sinai

Phone: 212-523-3812

Email: ingrid.sanabria@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place