Trial Outcomes & Findings for A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis (NCT NCT01610596)
NCT ID: NCT01610596
Last Updated: 2016-05-13
Results Overview
Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment "success" at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Day 15
Results posted on
2016-05-13
Participant Flow
Recruitment period: November 2011 to February 2012 The location of clinical sites included dermatology clinical research centers.
All subjects who met the entry criteria were randomized and enrolled into the study.
Participant milestones
| Measure |
Halobetasol Propionate Lotion 0.05%
Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week
|
Vehicle Lotion
Topical lotion, applied twice daily
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Halobetasol Propionate Lotion 0.05%
Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week
|
Vehicle Lotion
Topical lotion, applied twice daily
Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Halobetasol Propionate Lotion 0.05%
n=36 Participants
Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
|
Vehicle Lotion
n=36 Participants
Topical lotion, applied twice daily
Placebo
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 13.06 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Overall Disease Severity at Baseline
Clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Overall Disease Severity at Baseline
Almost clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Overall Disease Severity at Baseline
Mild
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Overall Disease Severity at Baseline
Moderate
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Overall Disease Severity at Baseline
Severe/very severe
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (scaling)
Clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (scaling)
Almost clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (scaling)
Mild
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (scaling)
Moderate
|
22 participants
n=5 Participants
|
28 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (scaling)
Severe/very severe
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (erythema)
Clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (erythema)
Almost clear
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (erythema)
Mild
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (erythema)
Moderate
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (erythema)
Severe/very severe
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (plaque elevation)
Clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (plaque elevation)
Almost clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (plaque elevation)
Mild
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (plaque elevation)
Moderate
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Signs of Psoriasis at Baseline (plaque elevation)
Severe/very severe
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Pruritus at Baseline
None
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Pruritus at Baseline
Mild
|
14 participants
n=5 Participants
|
5 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Pruritus at Baseline
Mild to moderate
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Pruritus at Baseline
Moderate
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Pruritus at Baseline
Moderal to severe
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Pruritus at Baseline
Severe
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Percent BSA to be Treated at Baseline
|
3.7 %BSA
STANDARD_DEVIATION 1.74 • n=5 Participants
|
4.0 %BSA
STANDARD_DEVIATION 2.04 • n=7 Participants
|
3.8 %BSA
STANDARD_DEVIATION 1.88 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Analysis shown is the Intent-to-treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment "success" at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale.
Outcome measures
| Measure |
Halobetasol Propionate Lotion 0.05%
n=36 Participants
Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
|
Vehicle Lotion
n=35 Participants
Topical lotion, applied twice daily
Placebo
|
|---|---|---|
|
Overall Disease Severity Score (Success)
|
30.6 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Days 8 and 15Population: Analysis shown is based on the ITT population.
Changes in percent BSA with active psoriasis in the Treatment Area
Outcome measures
| Measure |
Halobetasol Propionate Lotion 0.05%
n=36 Participants
Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
|
Vehicle Lotion
n=35 Participants
Topical lotion, applied twice daily
Placebo
|
|---|---|---|
|
Percent Body Surface Area
at Day 8
|
-0.3 Change in %BSA
Standard Deviation 0.57
|
-0.1 Change in %BSA
Standard Deviation 0.34
|
|
Percent Body Surface Area
at Day 15
|
-1.3 Change in %BSA
Standard Deviation 1.34
|
-0.2 Change in %BSA
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Days 8 and 15Population: Analysis shown is based on the ITT population.
The proportion of subjects rated a "treatment success" for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque elevation and pruritis. "Treatment success" is defined as a score of 0 or 1 on a five-point scale ranging from 0 = clear to 4 = severe/very severe.
Outcome measures
| Measure |
Halobetasol Propionate Lotion 0.05%
n=36 Participants
Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
|
Vehicle Lotion
n=35 Participants
Topical lotion, applied twice daily
Placebo
|
|---|---|---|
|
Clinical Signs and Symptoms of Psoriasis
Scaling (Day 8)
|
25.0 percentage of participants
|
8.6 percentage of participants
|
|
Clinical Signs and Symptoms of Psoriasis
Scaling (Day 15)
|
61.1 percentage of participants
|
11.4 percentage of participants
|
|
Clinical Signs and Symptoms of Psoriasis
Erythema (Day 8)
|
2.9 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Signs and Symptoms of Psoriasis
Erythema (Day 15)
|
13.9 percentage of participants
|
2.9 percentage of participants
|
|
Clinical Signs and Symptoms of Psoriasis
Plaque elevation (Day 8)
|
11.1 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Signs and Symptoms of Psoriasis
Plaque elevation (Day 15)
|
38.9 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: Days 8 and 15The proportion of subjects rated a "improved" for ODS at Day 8 and Day 15. "Improvement" is defined as at least a two (2) grade decrease in severity score relative to baseline using a five-point scale ranging from 0 = clear to 4 = severe/very severe.
Outcome measures
| Measure |
Halobetasol Propionate Lotion 0.05%
n=36 Participants
Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
|
Vehicle Lotion
n=35 Participants
Topical lotion, applied twice daily
Placebo
|
|---|---|---|
|
Overall Disease Severity Score (Improvement)
at Day 8
|
13.9 percentage of participants
|
0.0 percentage of participants
|
|
Overall Disease Severity Score (Improvement)
at Day 15
|
44.4 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Halobetasol Propionate Lotion 0.05%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Vehicle Lotion
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Halobetasol Propionate Lotion 0.05%
n=36 participants at risk
Topical lotion, applied twice daily
Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week
|
Vehicle Lotion
n=36 participants at risk
Topical lotion, applied twice daily
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
2.8%
1/36 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.8%
1/36 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
General disorders
Application site atrophy
|
5.6%
2/36 • Number of events 2 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
General disorders
Application site discoloration
|
2.8%
1/36 • Number of events 2 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
General disorders
Application site pain
|
8.3%
3/36 • Number of events 3 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
8.3%
3/36 • Number of events 3 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Infections and infestations
Herpes zoster
|
2.8%
1/36 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Investigations
Blood pressure increased
|
2.8%
1/36 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.8%
1/36 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
2.8%
1/36 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.8%
1/36 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
2.8%
1/36 • Number of events 1 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
0.00%
0/36 • Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all participants enrolled in the study who were dispensed the test article at least once; all participants enrolled in the study applied the first application in the clinic and were included in the Safety population.
|
Additional Information
Clinical Research, Therapeutics Inc.
Therapeutics, Inc.
Phone: 858-571-1800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER