Psoriasis
Conditions
Keywords
Psoriasis, Topical corticosteroids, Plaque psoriasis
Brief summary
The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients with moderate to severe plaque psoriasis.
Interventions
DRUGDesoximetasone 0.05% once daily
Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
DRUGDesoximetasone 0.05% twice daily
Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
DRUGDesoximetasone 0.25% once daily
Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
DRUGVehicle once daily
Vehicle topical spray administered to affected areas once daily for 28 days
DRUGVehicle twice daily
Vehicle topical spray administered to affected areas twice daily for 28 days
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
* Pregnancy * Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study. * History of psoriasis that has been unresponsive to topical corticosteroid therapy. * Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis. * Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study. * Any condition that would place the study patient at undue risk by participation in the study. * Radiation therapy, antineoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug. * Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the first dose of study drug. * Treatment within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. * 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. * Hormonal contraceptives for less than one complete cycle prior to entering the study. * 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 |
|---|---|---|
| Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 | 28 days | The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is \> 1, the patient was considered to have an insufficient therapeutic response |
| Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1). | Day 28 | The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in PGA Score at Day 28 Using the ITT | Day 28 | Physician Global Assessment (PGA) of Psoriasis is scored 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 plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease. |
| Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28 | Day 28 | Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. |
| Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination). | Day 28 | 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 %Body Surface Area Affected the Rule of Nine was be used. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desoximetasone 0.05% Once Daily Desoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days | 30 |
| Desoximetasone 0.05% Twice Daily Desoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days | 31 |
| Desoximetasone 0.25% Once Daily Desoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days | 30 |
| Desoximetasone 0.25% Twice Daily Desoximetasone topical spray 0.25% administered twice daily to affected area
Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days | 29 |
| Vehicle Once Daily Vehicle administered to affected areas once daily
Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days | 15 |
| Vehicle Twice Daily Vehicle administered to affected areas twice daily
Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days | 15 |
| Total | 150 |
Baseline characteristics
| Characteristic | Desoximetasone 0.05% Once Daily | Desoximetasone 0.05% Twice Daily | Desoximetasone 0.25% Once Daily | Desoximetasone 0.25% Twice Daily | Vehicle Once Daily | Vehicle Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.60 years STANDARD_DEVIATION 15.21 | 45.06 years STANDARD_DEVIATION 13.04 | 51.60 years STANDARD_DEVIATION 12.67 | 50.62 years STANDARD_DEVIATION 14.54 | 53.53 years STANDARD_DEVIATION 12.92 | 49.60 years STANDARD_DEVIATION 13.3 | 50.66 years STANDARD_DEVIATION 13.61 |
| Region of Enrollment United States | 30 participants | 31 participants | 30 participants | 29 participants | 15 participants | 15 participants | 150 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 14 Participants | 11 Participants | 1 Participants | 7 Participants | 58 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 16 Participants | 18 Participants | 14 Participants | 8 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 30 | 2 / 31 | 7 / 30 | 4 / 29 | 5 / 15 | 6 / 15 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 | 0 / 30 | 0 / 29 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28
The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is \> 1, the patient was considered to have an insufficient therapeutic response
Time frame: 28 days
Population: The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desoximetasone 0.05% Once Daily | Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 | 13.33 percentage of participants |
| Desoximetasone 0.05% Twice Daily | Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 | 10.00 percentage of participants |
| Desoximetasone 0.25% Once Daily | Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 | 20.69 percentage of participants |
| Desoximetasone 0.25% Twice Daily | Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 | 37.93 percentage of participants |
| Vehicle Once Daily | Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 | 6.67 percentage of participants |
| Vehicle Twice Daily | Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 | 6.67 percentage of participants |
p-value: 0.4261t-test, 1 sided
p-value: 0.4219t-test, 1 sided
p-value: 0.1826t-test, 1 sided
p-value: 0.009t-test, 1 sided
p-value: 0.3421t-test, 1 sided
p-value: 0.01t-test, 1 sided
p-value: 0.2103t-test, 1 sided
p-value: 0.12t-test, 1 sided
Primary
Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).
The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.
Time frame: Day 28
Population: The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desoximetasone 0.05% Once Daily | Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1). | 6.67 percentage of Participants |
| Desoximetasone 0.05% Twice Daily | Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1). | 16.67 percentage of Participants |
| Desoximetasone 0.25% Once Daily | Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1). | 34.48 percentage of Participants |
| Desoximetasone 0.25% Twice Daily | Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1). | 31.03 percentage of Participants |
| Vehicle Once Daily | Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1). | 6.67 percentage of Participants |
| Vehicle Twice Daily | Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1). | 6.67 percentage of Participants |
p-value: 0.2631t-test, 1 sided
p-value: 0.2968t-test, 1 sided
p-value: 0.0186t-test, 1 sided
p-value: 0.0361t-test, 1 sided
p-value: 0.007t-test, 1 sided
p-value: 0.1583t-test, 1 sided
p-value: 0.2078t-test, 1 sided
p-value: 0.2878t-test, 1 sided
Secondary
Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).
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 %Body Surface Area Affected the Rule of Nine was be used.
Time frame: Day 28
Population: The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desoximetasone 0.05% Once Daily | Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination). | 1.20 percentage of Body Surface Area Affected | Standard Deviation 2.44 |
| Desoximetasone 0.05% Twice Daily | Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination). | 0.00 percentage of Body Surface Area Affected | Standard Deviation 0.69 |
| Desoximetasone 0.25% Once Daily | Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination). | 1.31 percentage of Body Surface Area Affected | Standard Deviation 2.38 |
| Desoximetasone 0.25% Twice Daily | Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination). | 2.76 percentage of Body Surface Area Affected | Standard Deviation 3.92 |
| Vehicle Once Daily | Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination). | 0.60 percentage of Body Surface Area Affected | Standard Deviation 2.06 |
| Vehicle Twice Daily | Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination). | 0.33 percentage of Body Surface Area Affected | Standard Deviation 1.35 |
p-value: 0.2397Wilcoxon (Mann-Whitney)
p-value: 0.3794Wilcoxon (Mann-Whitney)
p-value: 0.0383Wilcoxon (Mann-Whitney)
p-value: 0.0154Wilcoxon (Mann-Whitney)
p-value: 0.1892Wilcoxon (Mann-Whitney)
p-value: 0.001Wilcoxon (Mann-Whitney)
p-value: 0.0363Wilcoxon (Mann-Whitney)
p-value: 0.2162Wilcoxon (Mann-Whitney)
Secondary
Mean Change From Baseline in PGA Score at Day 28 Using the ITT
Physician Global Assessment (PGA) of Psoriasis is scored 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 plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.
Time frame: Day 28
Population: The Intent-to-Treat (ITT) population was used for the secondary endpoint analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desoximetasone 0.05% Once Daily | Mean Change From Baseline in PGA Score at Day 28 Using the ITT | 0.63 units on a scale | Standard Deviation 0.93 |
| Desoximetasone 0.05% Twice Daily | Mean Change From Baseline in PGA Score at Day 28 Using the ITT | 0.57 units on a scale | Standard Deviation 0.68 |
| Desoximetasone 0.25% Once Daily | Mean Change From Baseline in PGA Score at Day 28 Using the ITT | 0.86 units on a scale | Standard Deviation 0.79 |
| Desoximetasone 0.25% Twice Daily | Mean Change From Baseline in PGA Score at Day 28 Using the ITT | 1.24 units on a scale | Standard Deviation 0.99 |
| Vehicle Once Daily | Mean Change From Baseline in PGA Score at Day 28 Using the ITT | 0.40 units on a scale | Standard Deviation 0.74 |
| Vehicle Twice Daily | Mean Change From Baseline in PGA Score at Day 28 Using the ITT | 0.67 units on a scale | Standard Deviation 0.62 |
p-value: 0.2713Wilcoxon (Mann-Whitney)
p-value: 0.2689Wilcoxon (Mann-Whitney)
p-value: 0.0419Wilcoxon (Mann-Whitney)
p-value: 0.0309Wilcoxon (Mann-Whitney)
p-value: 0.1126Wilcoxon (Mann-Whitney)
p-value: 0.0033Wilcoxon (Mann-Whitney)
p-value: 0.4967Wilcoxon (Mann-Whitney)
p-value: 0.0749Wilcoxon (Mann-Whitney)
Secondary
Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28
Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.
Time frame: Day 28
Population: The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desoximetasone 0.05% Once Daily | Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28 | 2.33 units on a scale | Standard Deviation 2.51 |
| Desoximetasone 0.05% Twice Daily | Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28 | 2.70 units on a scale | Standard Deviation 2.05 |
| Desoximetasone 0.25% Once Daily | Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28 | 3.79 units on a scale | Standard Deviation 3.2 |
| Desoximetasone 0.25% Twice Daily | Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28 | 4.55 units on a scale | Standard Deviation 3.03 |
| Vehicle Once Daily | Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28 | 2.80 units on a scale | Standard Deviation 2.21 |
| Vehicle Twice Daily | Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28 | 3.00 units on a scale | Standard Deviation 1.81 |
p-value: 0.2442Wilcoxon (Mann-Whitney)
p-value: 0.2664Wilcoxon (Mann-Whitney)
p-value: 0.1328Wilcoxon (Mann-Whitney)
p-value: 0.0528Wilcoxon (Mann-Whitney)
p-value: 0.0297Wilcoxon (Mann-Whitney)
p-value: 0.0093Wilcoxon (Mann-Whitney)
p-value: 0.223Wilcoxon (Mann-Whitney)
p-value: 0.1924Wilcoxon (Mann-Whitney)