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efficacy study in patients with moderate to severe plaque psoriasis.
A Double-Blind, Vehicle-Controlled, Randomized, Parallel Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients with Moderate to Severe Plaque Psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active product | Experimental | Desoximetasone Spray 0.25% |
|
| placebo comparator | Placebo Comparator | vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desoximetasone Spray 0.25% | Drug | Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear). | 28 days |
| Treatment Success | A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT. | In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges). The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novum Pharmaceutical Research Services | http://www.novumprs.com/contact | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28504031 | Derived | Saleem MD, Negus D, Feldman SR. Topical 0.25% desoximetasone spray efficacy for moderate to severe plaque psoriasis: a randomized clinical trial. J Dermatolog Treat. 2018 Feb;29(1):32-35. doi: 10.1080/09546634.2017.1331027. Epub 2017 May 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Desoximetasone Spray 0.25% | Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
| FG001 | Placebo | placebo comparator: Placebo administered to affected area twice a day for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desoximetasone Spray 0.25% | Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
| BG001 | Placebo | placebo comparator: Placebo administered to affected area twice a day for 28 days |
| 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 | Clinical Success | A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear). | Primary Efficacy Analysis at Day 28 Clinical Success (ITT) | Posted | Number | participants | 28 days |
|
3 months
Daily questionnaire
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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 | Desoximetasone Spray 0.25% | Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Dryness | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Taro Pharmaceuticals U.S.A., Inc | 914-345-9001 | natalie.yantovskiy@taro.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003899 | Desoximetasone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| placebo comparator | Drug | Placebo administered to affected area twice a day for 28 days |
|
|
| Baseline and day 28 |
| Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT) | Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT) TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance. | Baseline and day 28 |
| Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28 | Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis The Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared For the %Body Surface Area Affected the "Rule of Nine" was be used. Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline]. | Baseline and day 28 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Treatment Success | A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation). | Posted | Number | participants | 28 days |
|
|
|
|
| Secondary | Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT. | In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges). The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined. | All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed | Posted | Mean | Standard Deviation | units on a scale | Baseline and day 28 |
|
|
|
|
| Secondary | Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT) | Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT) TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance. | Base on intention to treat. All participant with mean change from baseline in TLSS at Day 28 | Posted | Mean | Standard Deviation | units on a scale | Baseline and day 28 |
|
|
|
|
| Secondary | Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28 | Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis The Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared For the %Body Surface Area Affected the "Rule of Nine" was be used. Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline]. | Base on intention to treat. All participant with Mean Change from Baseline in %BSA affected at Day 28 | Posted | Mean | Standard Deviation | percentage of body surface area affected | Baseline and day 28 |
|
|
|
|
| 0 |
| 60 |
| 17 |
| 60 |
| EG001 | Placebo | placebo comparator: Placebo administered to affected area twice a day for 28 days | 0 | 60 | 21 | 60 |
| Application Site Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Application Site Irritation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Application Site Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003907 | Dexamethasone |
| D013259 | Steroids, Fluorinated |