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Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 122-0551 | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 122-0551 | Drug | Applied twice daily for two weeks |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Disease Severity (ODS) Score | The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. | baseline and Day 15 (End of Study - EOS) |
| Measure | Description | Time Frame |
|---|---|---|
| ODS "Treatment Success" at Day 8 and Day 15 | The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. | baseline, Day 8, and Day 15 |
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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 | ||
| DermResearch, Inc. |
All subjects who met the entry criteria were randomized and enrolled into the study.
Recruitment period: May 2012 to September 2012
The location of clinical sites included dermatology clinical research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 122-0551 | 122-0551: Applied twice daily for two weeks |
| FG001 | Vehicle | Vehicle: Applied twice daily for two weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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 | 122-0551 | 122-0551: Applied twice daily for two weeks |
| BG001 | Vehicle | Vehicle: Applied twice daily for two weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Overall Disease Severity (ODS) Score | The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. | Analysis shown is the Intent-to-treat (ITT) population, defined as all participants who were randomized, applied at least one dose, and had at least one follow-up visit after the Baseline visit. One study participant (VEH group) did not return to the clinic (incarcerated) following Visit 1 (baseline visit) and was excluded from the ITT population. | Posted | Number | percentage of participants | baseline and Day 15 (End of Study - EOS) |
|
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 and applied 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 | 122-0551 | 122-0551: Applied twice daily for two weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research, Therapeutics Inc. | Therapeutics Inc. | 858-571-1800 | clinicalresearch@therapeuticsinc.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Drug |
Applied twice daily for two weeks |
|
| ODS "Improved" at Day 8 and Day 15 |
The percentage of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. |
| baseline, Day 8, and Day 15 |
| "Treatment Success" for Clinical Signs and Symptoms of Psoriasis | The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. | baseline, Day 8 and Day 15 |
| "Improved" for Clinical Signs and Symptoms of Psoriasis | The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. | baseline, Day 8 and Day 15 |
| Change in % Body Surface Area (BSA) With Psoriasis | Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15. | baseline, Day 8 and Day 15 |
| Austin |
| Texas |
| 78759 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Vehicle | Vehicle: Applied twice daily for two weeks |
|
|
|
| Secondary | ODS "Treatment Success" at Day 8 and Day 15 | The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. | Analysis shown is the Intent-to-treat (ITT) population. | Posted | Number | percentage of participants | baseline, Day 8, and Day 15 |
|
|
|
|
| Secondary | ODS "Improved" at Day 8 and Day 15 | The percentage of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. | Analysis shown is the Intent-to-treat (ITT) population. | Posted | Number | percentage of participants | baseline, Day 8, and Day 15 |
|
|
|
|
| Secondary | "Treatment Success" for Clinical Signs and Symptoms of Psoriasis | The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. | Analysis shown is the Intent-to-treat (ITT) population. | Posted | Number | percentage of participants | baseline, Day 8 and Day 15 |
|
|
|
| Secondary | "Improved" for Clinical Signs and Symptoms of Psoriasis | The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. | Analysis shown is the Intent-to-treat (ITT) population. | Posted | Number | percentage of participants | baseline, Day 8 and Day 15 |
|
|
|
| Secondary | Change in % Body Surface Area (BSA) With Psoriasis | Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15. | Analysis shown is the Intent-to-treat (ITT) population. The mean percent BSA at baseline was 4.8 for the active group (122-0551) and 4.6 for the vehicle group. | Posted | Mean | Standard Deviation | Change in percent BSA | baseline, Day 8 and Day 15 |
|
|
|
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Vehicle | Vehicle: Applied twice daily for two weeks | 0 | 21 | 0 | 21 | 3 | 21 |
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
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.
| Erythema (Day 8) |
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| Erythema (Day 15) |
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| Plaque Elevation (Day 8) |
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| Plaque Elevation (Day 15) |
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| Erythema (Day 8) |
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| Erythema (Day 15) |
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| Plaque Elevation (Day 8) |
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| Plaque Elevation (Day 15) |
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