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A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01610596
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : April 11, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Psoriasis
Plaque Psoriasis
Interventions Drug: Halobetasol Propionate Lotion 0.05%
Drug: Placebo
Enrollment 72
Recruitment Details

Recruitment period: November 2011 to February 2012

The location of clinical sites included dermatology clinical research centers.

Pre-assignment Details All subjects who met the entry criteria were randomized and enrolled into the study.
Arm/Group Title Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Hide Arm/Group Description

Topical lotion, applied twice daily

Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week

Topical lotion, applied twice daily

Placebo

Period Title: Overall Study
Started 36 36
Completed 36 35
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Halobetasol Propionate Lotion 0.05% Vehicle Lotion Total
Hide Arm/Group Description

Topical lotion, applied twice daily

Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week

Topical lotion, applied twice daily

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 36 36 72
Hide Baseline Analysis Population Description
Baseline analyses are based on the Safety population. All participants enrolled in the study who were dispensed and applied test article at least once.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 72 participants
50.0  (11.74) 52.3  (13.06) 51.2  (12.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Female
8
  22.2%
11
  30.6%
19
  26.4%
Male
28
  77.8%
25
  69.4%
53
  73.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Hispanic or Latino
11
  30.6%
3
   8.3%
14
  19.4%
Not Hispanic or Latino
25
  69.4%
33
  91.7%
58
  80.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
American Indian or Alaska Native
1
   2.8%
0
   0.0%
1
   1.4%
Asian
0
   0.0%
1
   2.8%
1
   1.4%
Native Hawaiian or Other Pacific Islander
1
   2.8%
0
   0.0%
1
   1.4%
Black or African American
1
   2.8%
1
   2.8%
2
   2.8%
White
32
  88.9%
34
  94.4%
66
  91.7%
More than one race
1
   2.8%
0
   0.0%
1
   1.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Overall Disease Severity at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Clear 0 0 0
Almost clear 0 0 0
Mild 0 0 0
Moderate 30 31 61
Severe/very severe 6 5 11
[1]
Measure Description: To be enrolled into the study, subjects had to have at least moderate ODS (score of at least 3). One study participant (vehicle group) did not return to the clinic (lost to follow-up) following Visit 1 (baseline visit) and was therefore excluded from the Intent-to-Treat (ITT) population.
Signs of Psoriasis at Baseline (scaling)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Clear 0 0 0
Almost clear 0 0 0
Mild 6 2 8
Moderate 22 28 50
Severe/very severe 8 6 14
[1]
Measure Description: One study participant (vehicle group) did not return to the clinic (lost to follow-up) following Visit 1 (baseline visit) and was therefore excluded from the Intent-to-Treat (ITT) population.
Signs of Psoriasis at Baseline (erythema)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Clear 0 0 0
Almost clear 1 0 1
Mild 1 1 2
Moderate 22 24 46
Severe/very severe 12 11 23
[1]
Measure Description: One study participant (vehicle group) did not return to the clinic (lost to follow-up) following Visit 1 (baseline visit) and was therefore excluded from the Intent-to-Treat (ITT) population.
Signs of Psoriasis at Baseline (plaque elevation)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Clear 0 0 0
Almost clear 0 0 0
Mild 2 3 5
Moderate 30 28 58
Severe/very severe 4 5 9
[1]
Measure Description: One study participant (vehicle group) did not return to the clinic (lost to follow-up) following Visit 1 (baseline visit) and was therefore excluded from the Intent-to-Treat (ITT) population.
Pruritus at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
None 3 8 11
Mild 14 5 19
Mild to moderate 12 11 23
Moderate 5 5 10
Moderal to severe 1 5 6
Severe 1 2 3
[1]
Measure Description: This evaluation is the participant's assessment of the itch on the active psoriasis plaques based on the 5-point Itch Evaluation Scoring Scale Form. One study participant (vehicle group) did not return to the clinic (lost to follow-up) following Visit 1 (baseline visit) and was therefore excluded from the Intent-to-Treat (ITT) population.
Percent BSA to be Treated at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  %BSA
Number Analyzed 36 participants 36 participants 72 participants
3.7  (1.74) 4.0  (2.04) 3.8  (1.88)
[1]
Measure Description: The percent Body Surface Area (BSA) with active psoriasis within the designated Treatment Area was assessed at Baseline. One study participant (vehicle group) did not return to the clinic (lost to follow-up) following Visit 1 (baseline visit) and was therefore excluded from the Intent-to-Treat (ITT) population.
1.Primary Outcome
Title Overall Disease Severity Score (Success)
Hide Description 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.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Hide Arm/Group Description:

Topical lotion, applied twice daily

Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week

Topical lotion, applied twice daily

Placebo

Overall Number of Participants Analyzed 36 35
Measure Type: Number
Unit of Measure: percentage of participants
30.6 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Halobetasol Propionate Lotion 0.05%, Vehicle Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percent Body Surface Area
Hide Description Changes in percent BSA with active psoriasis in the Treatment Area
Time Frame Baseline, Days 8 and 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the ITT population.
Arm/Group Title Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Hide Arm/Group Description:

Topical lotion, applied twice daily

Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week

Topical lotion, applied twice daily

Placebo

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: Change in %BSA
at Day 8 -0.3  (0.57) -0.1  (0.34)
at Day 15 -1.3  (1.34) -0.2  (0.93)
3.Secondary Outcome
Title Clinical Signs and Symptoms of Psoriasis
Hide Description 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.
Time Frame Days 8 and 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the ITT population.
Arm/Group Title Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Hide Arm/Group Description:

Topical lotion, applied twice daily

Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week

Topical lotion, applied twice daily

Placebo

Overall Number of Participants Analyzed 36 35
Measure Type: Number
Unit of Measure: percentage of participants
Scaling (Day 8) 25.0 8.6
Scaling (Day 15) 61.1 11.4
Erythema (Day 8) 2.9 0.0
Erythema (Day 15) 13.9 2.9
Plaque elevation (Day 8) 11.1 0.0
Plaque elevation (Day 15) 38.9 2.9
4.Secondary Outcome
Title Overall Disease Severity Score (Improvement)
Hide Description The 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.
Time Frame Days 8 and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Hide Arm/Group Description:

Topical lotion, applied twice daily

Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week

Topical lotion, applied twice daily

Placebo

Overall Number of Participants Analyzed 36 35
Measure Type: Number
Unit of Measure: percentage of participants
at Day 8 13.9 0.0
at Day 15 44.4 0.0
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Hide Arm/Group Description

Topical lotion, applied twice daily

Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week

Topical lotion, applied twice daily

Placebo

All-Cause Mortality
Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Halobetasol Propionate Lotion 0.05% Vehicle Lotion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/36 (30.56%)      5/36 (13.89%)    
Gastrointestinal disorders     
Diverticulum * 1  0/36 (0.00%)  0 1/36 (2.78%)  1
Gastroenteritis * 1  1/36 (2.78%)  1 0/36 (0.00%)  0
General disorders     
Application site atrophy * 1  2/36 (5.56%)  2 0/36 (0.00%)  0
Application site discoloration * 1  1/36 (2.78%)  2 0/36 (0.00%)  0
Application site pain * 1  3/36 (8.33%)  3 3/36 (8.33%)  3
Infections and infestations     
Herpes zoster * 1  1/36 (2.78%)  1 0/36 (0.00%)  0
Investigations     
Blood pressure increased * 1  1/36 (2.78%)  1 0/36 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint swelling * 1  1/36 (2.78%)  1 0/36 (0.00%)  0
Muscle spasms * 1  0/36 (0.00%)  0 1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection * 1  1/36 (2.78%)  1 0/36 (0.00%)  0
Skin and subcutaneous tissue disorders     
Telangiectasia * 1  1/36 (2.78%)  1 0/36 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research, Therapeutics Inc.
Organization: Therapeutics, Inc.
Phone: 858-571-1800
EMail: clinicalresearch@therapeuticsinc.com
Layout table for additonal information
Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01610596     History of Changes
Other Study ID Numbers: 000-0551-207
First Submitted: January 18, 2012
First Posted: June 4, 2012
Results First Submitted: March 10, 2016
Results First Posted: April 11, 2016
Last Update Posted: May 13, 2016