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This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Halobetasol Propionate Lotion 0.05% | Experimental | Topical lotion, applied twice daily |
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| Vehicle Lotion | Placebo Comparator | Topical lotion, applied twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halobetasol Propionate Lotion 0.05% | Drug | Apply twice daily for 1-2 weeks, not to exceed 50 grams per week |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Disease Severity Score (Success) | 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. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Body Surface Area | Changes in percent BSA with active psoriasis in the Treatment Area | Baseline, Days 8 and 15 |
| Clinical Signs and Symptoms of Psoriasis | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syd Dromgoole, PhD | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States | ||
| Minnesota Clinical Study Center |
All subjects who met the entry criteria were randomized and enrolled into the study.
Recruitment period: November 2011 to February 2012
The location of clinical sites included dermatology clinical research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Vehicle Lotion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug |
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| Days 8 and 15 |
| Overall Disease Severity Score (Improvement) | 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. | Days 8 and 15 |
| Fridley |
| Minnesota |
| 55432 |
| United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
Topical lotion, applied twice daily
Placebo
| COMPLETED |
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| NOT COMPLETED |
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Baseline analyses are based on the Safety population. All participants enrolled in the study who were dispensed and applied test article at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | Halobetasol Propionate Lotion 0.05% | Topical lotion, applied twice daily Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week |
| BG001 | Vehicle Lotion | Topical lotion, applied twice daily Placebo |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | 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 |
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| Overall Disease Severity at Baseline | 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. | Number | participants |
| |||||||||||||||
| Signs of Psoriasis at Baseline (scaling) | 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. | Number | participants |
| |||||||||||||||
| Signs of Psoriasis at Baseline (erythema) | 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. | Number | participants |
| |||||||||||||||
| Signs of Psoriasis at Baseline (plaque elevation) | 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. | Number | participants |
| |||||||||||||||
| Pruritus at Baseline | 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. | Number | participants |
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| Percent BSA to be Treated at Baseline | 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. | Mean | Standard Deviation | %BSA |
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| 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 | Overall Disease Severity Score (Success) | 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. | 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. | Posted | Number | percentage of participants | Day 15 |
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| Secondary | Percent Body Surface Area | Changes in percent BSA with active psoriasis in the Treatment Area | Analysis shown is based on the ITT population. | Posted | Mean | Standard Deviation | Change in %BSA | Baseline, Days 8 and 15 |
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| Secondary | Clinical Signs and Symptoms of Psoriasis | 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. | Analysis shown is based on the ITT population. | Posted | Number | percentage of participants | Days 8 and 15 |
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| Secondary | Overall Disease Severity Score (Improvement) | 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. | Posted | Number | percentage of participants | Days 8 and 15 |
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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.
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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 | 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 | 0 | 36 | 11 | 36 | ||
| EG001 | Vehicle Lotion | Topical lotion, applied twice daily Placebo | 0 | 36 | 5 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulum | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Application site atrophy | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Application site discoloration | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Application site pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research, Therapeutics Inc. | Therapeutics, Inc. | 858-571-1800 | clinicalresearch@therapeuticsinc.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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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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| Almost clear |
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| Mild |
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| Moderate |
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| Severe/very severe |
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| Almost clear |
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| Mild |
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| Moderate |
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| Severe/very severe |
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| Almost clear |
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| Mild |
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| Moderate |
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| Severe/very severe |
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| Almost clear |
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| Mild |
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| Moderate |
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| Severe/very severe |
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| Mild |
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| Mild to moderate |
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| Moderate |
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| Moderal to severe |
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| Severe |
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