Psoriasis
Conditions
Brief summary
efficacy study in patients with moderate to severe plaque psoriasis.
Detailed description
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
Interventions
Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
DRUGplacebo comparator
Placebo administered to affected area twice a day for 28 days
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant, non-lactating female 18 years of age or older. * Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA). * Have a combined total lesion severity score (TLSS) of ≥ 7 for the Target Lesion. * Have a plaque elevation score ≥ 3 of (moderate) for the Target Lesion. * The Target Lesion must have an area of at least 5 cm². * Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
Exclusion criteria
* Patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. Nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp. * Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy. * In the Investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis. * Patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study. * Patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. * Patient has received any systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study. * Patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study. * Receipt of any drug as part of a research study within 30 days prior to first dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 28 days | A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear). |
| Treatment Success | 28 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT. | Baseline and day 28 | 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. |
| Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT) | Baseline and day 28 | 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. |
| Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28 | Baseline and 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 \[Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline\]. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desoximetasone Spray 0.25% Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days | 60 |
| Placebo placebo comparator: Placebo administered to affected area twice a day for 28 days | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Desoximetasone Spray 0.25% | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical >=65 years | 10 Participants | 17 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 29 Participants | 65 Participants |
| Age, Continuous | 50.67 years STANDARD_DEVIATION 13.86 | 52.55 years STANDARD_DEVIATION 15.56 | 51.61 years STANDARD_DEVIATION 14.71 |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 42 Participants | 43 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 60 | 21 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Clinical Success
A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).
Time frame: 28 days
Population: Primary Efficacy Analysis at Day 28 Clinical Success (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desoximetasone Spray 0.25% | Clinical Success | 18 participants |
| Placebo | Clinical Success | 3 participants |
p-value: 0.0003t-test, 2 sided
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).
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desoximetasone Spray 0.25% | Treatment Success | 23 participants |
| Placebo | Treatment Success | 4 participants |
p-value: <0.0001t-test, 2 sided
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 \[Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline\].
Time frame: Baseline and day 28
Population: Base on intention to treat. All participant with Mean Change from Baseline in %BSA affected at Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desoximetasone Spray 0.25% | Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28 | 2.24 percentage of body surface area affected | Standard Deviation 3.79 |
| Placebo | Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28 | 0.37 percentage of body surface area affected | Standard Deviation 2.05 |
p-value: 0.0011t-test, 2 sided
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.
Time frame: Baseline and day 28
Population: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desoximetasone Spray 0.25% | Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT. | 1.14 units on a scale | Standard Deviation 0.9 |
| Placebo | Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT. | 0.50 units on a scale | Standard Deviation 0.68 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: Baseline and day 28
Population: Base on intention to treat. All participant with mean change from baseline in TLSS at Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desoximetasone Spray 0.25% | Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT) | 4.73 units on a scale | Standard Deviation 3.08 |
| Placebo | Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT) | 1.93 units on a scale | Standard Deviation 1.96 |
p-value: <0.0001t-test, 2 sided