Psoriasis
Conditions
Brief summary
The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is effective for the treatment of patients with moderate to severe plaque psoriasis.
Interventions
Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
DRUGplacebo
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 ITT | 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 | Day 28 | 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 the three signs and symptoms (erythema, scaling and plaque elevation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Assessment (PGA) of Psoriasis Score at Day 28. | Day 28 | Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desoximetasone Spray 0.25% Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days | 60 |
| Placebo Placebo administered to affected area twice a day for 28 days
placebo: 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 | 17 Participants | 13 Participants | 30 Participants |
| Age, Categorical >=65 years | 9 Participants | 16 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 31 Participants | 65 Participants |
| Age, Continuous | 48.03 years STANDARD_DEVIATION 14.29 | 53.55 years STANDARD_DEVIATION 14.82 | 50.79 years STANDARD_DEVIATION 14.56 |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 23 Participants | 25 Participants | 48 Participants |
| Sex: Female, Male Male | 37 Participants | 35 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 60 | 5 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Clinical Success ITT
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: Analysis was conducted using Intent-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desoximetasone Spray 0.25% | Clinical Success ITT | 32 participants |
| Placebo | Clinical Success ITT | 11 participants |
p-value: <0.0001t-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 the three signs and symptoms (erythema, scaling and plaque elevation).
Time frame: Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desoximetasone Spray 0.25% | Treatment Success | 32 participants |
| Placebo | Treatment Success | 10 participants |
p-value: <0.0001t-test, 2 sided
Secondary
Physician's Global Assessment (PGA) of Psoriasis Score at Day 28.
Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.
Time frame: Day 28
Population: ITT Population. Participants who returned for at least one post baseline visit and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desoximetasone Spray 0.25% | Physician's Global Assessment (PGA) of Psoriasis Score at Day 28. | 1.73 units on a scale | Standard Deviation 1.06 |
| Placebo | Physician's Global Assessment (PGA) of Psoriasis Score at Day 28. | 0.85 units on a scale | Standard Deviation 0.94 |
p-value: <0.0001t-test, 2 sided