Trial Outcomes & Findings for The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients (NCT NCT03848871)
NCT ID: NCT03848871
Last Updated: 2020-08-26
Results Overview
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
screening/baseline, week 2, week 4
Results posted on
2020-08-26
Participant Flow
Participant milestones
| Measure |
Enstilar Foam
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Enstilar Foam
n=20 Participants
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=20 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 16 • n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: screening/baseline, week 2, week 4Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Outcome measures
| Measure |
Enstilar Foam
n=20 Participants
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Baseline · Moderate
|
20 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Baseline · Mild
|
0 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Baseline · Almost Clear
|
0 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Baseline · Clear
|
0 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Week 2 · Moderate
|
1 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Week 2 · Mild
|
13 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Week 2 · Almost Clear
|
6 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Week 2 · Clear
|
0 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Week 4 · Moderate
|
1 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Week 4 · Mild
|
4 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Week 4 · Almost Clear
|
9 Participants
|
|
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Week 4 · Clear
|
6 Participants
|
SECONDARY outcome
Timeframe: screening/baseline, week 2, week 4Size of target lesion recorded as height in cm x length in cm
Outcome measures
| Measure |
Enstilar Foam
n=20 Participants
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Change in Lesion Size From Baseline to Week 2 and Week 4
Baseline
|
19 cm^2
Standard Deviation 14
|
|
Change in Lesion Size From Baseline to Week 2 and Week 4
Week 2
|
16 cm^2
Standard Deviation 13
|
|
Change in Lesion Size From Baseline to Week 2 and Week 4
Week 4
|
10 cm^2
Standard Deviation 8
|
SECONDARY outcome
Timeframe: screening/baseline, week 2, week 4Percent of total body surface affected by psoriasis, calculated by multiplying the percent of a specified body area affected by psoriasis x the percent of total body surface area represented by the specified area (where head = 10% of total body surface, trunk = 30%, upper limbs = 20%, lower limbs = 40%)
Outcome measures
| Measure |
Enstilar Foam
n=20 Participants
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
Baseline
|
9.8 percentage of body covered by psoriasis
Standard Deviation 6.8
|
|
Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
Week 2
|
9.2 percentage of body covered by psoriasis
Standard Deviation 6.9
|
|
Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
Week 4
|
6.9 percentage of body covered by psoriasis
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: screening/baseline, week 2, week 4Population: Erythema assessment
A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 1= slightly pink, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion
Outcome measures
| Measure |
Enstilar Foam
n=20 Participants
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Baseline · 8 Extremely Red
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Baseline · 6 Very Red
|
5 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Baseline · 4 Red
|
13 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Baseline · 2 Pink
|
2 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Baseline · 1 Slightly Pink
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Baseline · 0 None
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 2 · 8 Extremely Red
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 2 · 6 Very Red
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 2 · 4 Red
|
4 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 2 · 2 Pink
|
14 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 2 · 1 Slightly Pink
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 2 · 0 None
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 4 · 8 Extremely Red
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 4 · 6 Very Red
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 4 · 4 Red
|
4 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 4 · 2 Pink
|
7 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 4 · 1 Slightly Pink
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Week 4 · 0 None
|
8 Participants
|
SECONDARY outcome
Timeframe: screening/baseline, week 2, week 4Population: Induration assessment
A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 1=very slight, 2=slight definite elevation above normal skin level, 3=mild, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion
Outcome measures
| Measure |
Enstilar Foam
n=20 Participants
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Baseline · 6 Marked
|
5 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Baseline · 4 Moderate
|
13 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Baseline · 3 Mild
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Baseline · 2 Slight
|
2 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Baseline · 1 Very Slight
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Baseline · 0 None
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 2 · 6 Marked
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 2 · 4 Moderate
|
3 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 2 · 3 Mild
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 2 · 2 Slight
|
9 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 2 · 1 Very Slight
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 2 · 0 None
|
6 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 4 · 6 Marked
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 4 · 4 Moderate
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 4 · 3 Mild
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 4 · 2 Slight
|
8 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 4 · 1 Very Slight
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Week 4 · 0 None
|
11 Participants
|
SECONDARY outcome
Timeframe: screening/baseline, week 2, week 4Population: Scaling assessment
A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion)
Outcome measures
| Measure |
Enstilar Foam
n=20 Participants
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Baseline · 8 Very Severe
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Baseline · 6 Severe
|
7 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Baseline · 4 Moderate
|
12 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Baseline · 2 Mild
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Baseline · 0 None
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 2 · 8 Very Severe
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 2 · 6 Severe
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 2 · 4 Moderate
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 2 · 2 Mild
|
10 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 2 · 0 None
|
9 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 4 · 8 Very Severe
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 4 · 6 Severe
|
0 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 4 · 4 Moderate
|
1 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 4 · 2 Mild
|
4 Participants
|
|
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Week 4 · 0 None
|
15 Participants
|
Adverse Events
Enstilar Foam
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enstilar Foam
n=20 participants at risk
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Enstilar: Enstilar foam applied to affected area once daily
|
|---|---|
|
Gastrointestinal disorders
GERD exacerbation
|
5.0%
1/20 • Number of events 1 • 4 weeks average, from signing of Informed consent until end of study participation
|
|
Respiratory, thoracic and mediastinal disorders
dry cough
|
5.0%
1/20 • Number of events 1 • 4 weeks average, from signing of Informed consent until end of study participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place