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The purpose of this study is to determine whether the investigational lotion is an effective treatment of moderate to severe plaque psoriasis in comparison to an approved cream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Halobetasol Proprionate Lotion 0.05% | Experimental | Subjects randomized to receive lotion |
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| Halobetasol Proprionate Cream 0.05% | Active Comparator | Subjects randomized to receive cream |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halobetasol Proprionate Lotion 0.05% | Drug | Apply 3.5 grams twice daily for 1-2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Adrenal Suppression Potential | Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment. | After 1-2 weeks dose |
| Pharmacokinetic Properties (Cmax) | Comparison of PK results (peak concentration in plasma [Cmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. | Day 8 |
| Pharmacokinetic Properties (Tmax) | Comparison of PK results (time to peak concentration [Tmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. | Day 8 |
| Pharmacokinetic Properties (AUC) | Comparison of PK results (area under the curve [AUC] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Disease Severity (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. ODS evaluations will be dichotomized to "success" and "failure" with success defined as a grade of 1 or 0 at the end of treatment (EOT). | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States | ||
| Michigan Center for Skin Care Research (dba Skin Care Research) |
All subjects who met the entry criteria were randomized and enrolled into the study.
Recruitment period: August 2010 to May 2011
The location of clinical sites included private dermatology clinics and clinical research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Halobetasol Proprionate Lotion 0.05% | Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks |
| FG001 | Halobetasol Proprionate Cream 0.05% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Halobetasol Proprionate Cream 0.05% | Drug | Apply 3.5 grams twice daily for 1-2 weeks |
|
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| Number of Subjects Whose Signs of Psoriasis Was Designated "Success" |
Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) "success" and "failure" with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared [Day 8 or Day 15] or end of the assigned treatment period). |
| Day 15 |
| Clinton Township |
| Michigan |
| 48038 |
| United States |
| Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas PLLC | Charlotte | North Carolina | 28207 | United States |
| DermResearch Inc. | Austin | Texas | 78759 | United States |
Subjects randomized to receive cream
Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
| COMPLETED |
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| NOT COMPLETED |
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The Intent-To-Treat (ITT) population included all participants enrolled in the study who were dispensed and applied test article at least once and had at least one follow-up visit after the Baseline visit (Visit 2). All 43 enrolled subjects were included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Halobetasol Proprionate Lotion 0.05% | Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks |
| BG001 | Halobetasol Proprionate Cream 0.05% | Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks |
| 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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| 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 | Adrenal Suppression Potential | Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment. | Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. | Posted | Number | participants | After 1-2 weeks dose |
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| Primary | Pharmacokinetic Properties (Cmax) | Comparison of PK results (peak concentration in plasma [Cmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. | Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 8 |
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| Primary | Pharmacokinetic Properties (Tmax) | Comparison of PK results (time to peak concentration [Tmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. | Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm. | Posted | Geometric Mean | Full Range | Hours | Day 8 |
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| Primary | Pharmacokinetic Properties (AUC) | Comparison of PK results (area under the curve [AUC] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. | Pharmacokinetics properties were evaluated in a subgroup of 12 adult subjects per arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | Day 8 |
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| Secondary | Changes in Disease Severity (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. ODS evaluations will be dichotomized to "success" and "failure" with success defined as a grade of 1 or 0 at the end of treatment (EOT). | Analysis shown is based on the ITT population at Day 15. | Posted | Number | participants | Day 15 |
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| Secondary | Number of Subjects Whose Signs of Psoriasis Was Designated "Success" | Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) "success" and "failure" with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared [Day 8 or Day 15] or end of the assigned treatment period). | Analysis shown is based on the number of subjects whose Signs of Psoriasis was designated "Success" (ITT population) at Day 15. | Posted | Number | participants | Day 15 |
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AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
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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 Proprionate Lotion 0.05% | Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for 1-2 weeks | 0 | 21 | 9 | 21 | ||
| EG001 | Halobetasol Proprionate Cream 0.05% | Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for 1-2 weeks | 0 | 22 | 8 | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Type 2 diabetes mellitus | Endocrine disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Application site pain | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Pallor | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| nasopharyngitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Throat infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
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| ACTH stimulation test abnormal | Investigations | MedDRA (13.1) | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Renal pain | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.1) | 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 dissemination. 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 |
|---|---|
| C064466 | halobetasol |
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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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