Plaque Psoriasis
Conditions
Brief summary
The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.
Detailed description
To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque psoriasis.
Interventions
DRUGDSXS
active treatment
DRUGPlacebo
placebo treatment
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
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis
Exclusion criteria
* patient is\< 12 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 | 28 Days | The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1. |
| Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 | 28 Days | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | 28 Days | The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success. |
| Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | 28 Days | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 3. |
| Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | 28 Days | The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success. |
| Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | 28 Days | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSXS1505 To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.
DSXS: active treatment
Placebo: placebo treatment | 60 |
| Placebo Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.
DSXS: active treatment
Placebo: placebo treatment | 59 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other Reasons | 1 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | DSXS1505 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 15.2 | 57.3 years STANDARD_DEVIATION 14.3 | 55.4 years STANDARD_DEVIATION 14.8 |
| Baseline Erythema Score Almost Clear | 1 Participants | 1 Participants | 2 Participants |
| Baseline Erythema Score Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline Erythema Score Mild | 15 Participants | 16 Participants | 31 Participants |
| Baseline Erythema Score Moderate | 40 Participants | 37 Participants | 77 Participants |
| Baseline Erythema Score Severe | 4 Participants | 5 Participants | 9 Participants |
| Baseline Erythema Score Very Severe | 0 Participants | 0 Participants | 0 Participants |
| Baseline Investigator's Global Assessment (IGA) Score Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline Investigator's Global Assessment (IGA) Score Mild | 16 Participants | 10 Participants | 26 Participants |
| Baseline Investigator's Global Assessment (IGA) Score Minimal | 0 Participants | 0 Participants | 0 Participants |
| Baseline Investigator's Global Assessment (IGA) Score Moderate | 44 Participants | 49 Participants | 93 Participants |
| Baseline Investigator's Global Assessment (IGA) Score Severe | 0 Participants | 0 Participants | 0 Participants |
| Baseline Plaque Elevation Almost Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline Plaque Elevation Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline Plaque Elevation Mild | 14 Participants | 11 Participants | 25 Participants |
| Baseline Plaque Elevation Moderate | 43 Participants | 43 Participants | 86 Participants |
| Baseline Plaque Elevation Severe | 3 Participants | 5 Participants | 8 Participants |
| Baseline Plaque Elevation Very Severe | 0 Participants | 0 Participants | 0 Participants |
| Baseline Psoriasis Area Severity Index (PASI) Score | 5.8 units on a scale STANDARD_DEVIATION 2.5 | 6.2 units on a scale STANDARD_DEVIATION 2.4 | 6.0 units on a scale STANDARD_DEVIATION 2.5 |
| Baseline Scaling Score Almost Clear | 1 Participants | 3 Participants | 4 Participants |
| Baseline Scaling Score Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline Scaling Score Mild | 15 Participants | 15 Participants | 30 Participants |
| Baseline Scaling Score Moderate | 40 Participants | 35 Participants | 75 Participants |
| Baseline Scaling Score Severe | 4 Participants | 6 Participants | 10 Participants |
| Baseline Scaling Score Very Severe | 0 Participants | 0 Participants | 0 Participants |
| Baseline Total BSA | 2.0 meters squared STANDARD_DEVIATION 0.3 | 2.0 meters squared STANDARD_DEVIATION 0.3 | 2.0 meters squared STANDARD_DEVIATION 0.3 |
| Baseline Total Lesion Severity Score (TLSS) | 8.4 units on a scale STANDARD_DEVIATION 1.4 | 8.4 units on a scale STANDARD_DEVIATION 1.5 | 8.4 units on a scale STANDARD_DEVIATION 1.5 |
| %BSA Affected with Psoriasis | 7.2 percent of BSA STANDARD_DEVIATION 1.5 | 7.5 percent of BSA STANDARD_DEVIATION 1.7 | 7.3 percent of BSA STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 28 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 31 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 56 Participants | 54 Participants | 110 Participants |
| Sex: Female, Male Female | 27 Participants | 23 Participants | 50 Participants |
| Sex: Female, Male Male | 33 Participants | 36 Participants | 69 Participants |
| Target Lesion Size (area) | 48.7 centimeters squared STANDARD_DEVIATION 55.1 | 36.7 centimeters squared STANDARD_DEVIATION 26.3 | 42.7 centimeters squared STANDARD_DEVIATION 43.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 59 |
| other Total, other adverse events | 3 / 60 | 3 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
Primary
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2
The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1.
Time frame: 28 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS1505 | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 | 10 Participants |
| Placebo | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 | 3 Participants |
p-value: 0.0745Cochran-Mantel-Haenszel
Primary
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2.
Time frame: 28 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS1505 | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 | 8 Participants |
| Placebo | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 | 4 Participants |
p-value: 0.231Cochran-Mantel-Haenszel
Secondary
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)
The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success.
Time frame: 28 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS1505 | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | 2 Participants |
| Placebo | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | 0 Participants |
p-value: 1Cochran-Mantel-Haenszel
Secondary
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)
The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success.
Time frame: 28 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS1505 | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | 8 Participants |
| Placebo | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | 3 Participants |
p-value: 0.1059Cochran-Mantel-Haenszel
Secondary
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 2.
Time frame: 28 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS1505 | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | 16 Participants |
| Placebo | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | 10 Participants |
p-value: 0.1044Cochran-Mantel-Haenszel
Secondary
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 3.
Time frame: 28 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS1505 | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | 4 Participants |
| Placebo | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | 3 Participants |
p-value: 0.6962Cochran-Mantel-Haenszel