Scalp Psoriasis
Conditions
Brief summary
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with Mild to Severe Scalp Psoriasis
Detailed description
To evaluate the therapeutic efficacy and safety of DSXS topical product (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Vehicle topical product (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to severe scalp psoriasis.
Interventions
DRUGDSXS topical
topical treatment
DRUGVehicle topical
topical 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
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or non-pregnant, non-lactating females 18 years of age and older.
Exclusion criteria
* Females who are pregnant, lactating or likely to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success | Day 29 | Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSXS Topical applied once daily for 28 days
DSXS topical: topical treatment | 186 |
| Vehicle Topical applied once daily for 28 days
Vehicle topical: topical treatment | 184 |
| Total | 370 |
Baseline characteristics
| Characteristic | DSXS Topical | Total | Vehicle Topical |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 15.9 | 50.1 years STANDARD_DEVIATION 16.3 | 49.3 years STANDARD_DEVIATION 16.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 84 Participants | 167 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 203 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis > 1 Year And <= 3 Years | 38 Participants | 71 Participants | 33 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis <= 3 Months | 18 Participants | 37 Participants | 19 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis > 3 Months And <= 6 Months | 1 Participants | 4 Participants | 3 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis > 3 Years And <= 5 Years | 19 Participants | 50 Participants | 31 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis > 5 Years | 102 Participants | 194 Participants | 92 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis > 6 Months And <= 1 Year | 8 Participants | 14 Participants | 6 Participants |
| Percent Scalp Affected | 33.7 percent STANDARD_DEVIATION 26 | 31.4 percent STANDARD_DEVIATION 25 | 29.2 percent STANDARD_DEVIATION 23.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 18 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 171 Participants | 338 Participants | 167 Participants |
| Region of Enrollment United States | 186 participants | 370 participants | 184 participants |
| Sex: Female, Male Female | 108 Participants | 219 Participants | 111 Participants |
| Sex: Female, Male Male | 78 Participants | 151 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 183 | 0 / 183 |
| other Total, other adverse events | 31 / 183 | 42 / 183 |
| serious Total, serious adverse events | 0 / 183 | 0 / 183 |
Outcome results
Primary
Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success
Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2
Time frame: Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS Topical | Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success | 49 Participants |
| Vehicle Topical | Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success | 41 Participants |
p-value: 0.2961Cochran-Mantel-Haenszel