Plaque Psoriasis
Conditions
Brief summary
The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.
Detailed description
This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.
Interventions
DRUGDSXS1411
DSXS (Taro Pharmaceuticals Inc.)
DRUGPlacebo
Placebo (vehicle) (Taro Pharmaceuticals Inc.)
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant, non-lactating females age 12 and older. * Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.
Exclusion criteria
* Under 12 years of age. * Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study. * Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response of Success | 28 Days | The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSXS1411 5 Min DSXS applied once a day for a total of 28 days for duration of 5 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.) | 24 |
| Placebo 5 Min Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) | 12 |
| DSXS1411 10 Min DSXS applied once a day for a total of 28 days for duration of 10 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.) | 26 |
| Placebo 10 Min Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) | 12 |
| DSXS1411 15 Min DSXS applied once a day for a total of 28 days for duration of 15 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.) | 22 |
| Placebo 15 Min Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) | 12 |
| DSXS1411 30 Min DSXS applied once a day for a total of 28 days for duration of 30 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.) | 25 |
| Placebo 30 Min Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) | 15 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 |
| Overall Study | Progressive Disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo 5 Min | DSXS1411 10 Min | Placebo 10 Min | DSXS1411 15 Min | DSXS1411 5 Min | Placebo 15 Min | DSXS1411 30 Min | Placebo 30 Min | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized < 18 | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Age, Customized 18 - 40 | 4 Participants | 5 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 5 Participants | 10 Participants | 45 Participants |
| Age, Customized 41 - 64 | 4 Participants | 18 Participants | 5 Participants | 14 Participants | 13 Participants | 5 Participants | 13 Participants | 4 Participants | 76 Participants |
| Age, Customized 65 - 75 | 3 Participants | 3 Participants | 0 Participants | 4 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 19 Participants |
| Age, Customized > 75 | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants | 7 Participants | 9 Participants | 5 Participants | 7 Participants | 4 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 18 Participants | 8 Participants | 15 Participants | 15 Participants | 7 Participants | 18 Participants | 11 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 24 Participants | 9 Participants | 22 Participants | 23 Participants | 11 Participants | 23 Participants | 15 Participants | 137 Participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 7 Participants | 14 Participants | 12 Participants | 8 Participants | 12 Participants | 10 Participants | 92 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants | 8 Participants | 12 Participants | 4 Participants | 13 Participants | 5 Participants | 56 Participants |
| Time Patient has Suffered from Symptoms > 1 Year And <= 3 Years | 3 Participants | 3 Participants | 4 Participants | 6 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 29 Participants |
| Time Patient has Suffered from Symptoms < 3 Months | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Time Patient has Suffered from Symptoms 3 to 6 Months | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Time Patient has Suffered from Symptoms > 3 Years And <= 5 Years | 0 Participants | 6 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 2 Participants | 4 Participants | 21 Participants |
| Time Patient has Suffered from Symptoms > 5 Years | 8 Participants | 16 Participants | 4 Participants | 12 Participants | 13 Participants | 6 Participants | 19 Participants | 5 Participants | 83 Participants |
| Time Patient has Suffered from Symptoms 6 to 12 Months | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 10 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 12 | 0 / 26 | 0 / 12 | 0 / 22 | 0 / 12 | 0 / 25 | 0 / 15 |
| other Total, other adverse events | 4 / 24 | 3 / 12 | 3 / 26 | 3 / 12 | 4 / 22 | 4 / 12 | 7 / 25 | 5 / 15 |
| serious Total, serious adverse events | 0 / 24 | 0 / 12 | 0 / 26 | 0 / 12 | 0 / 22 | 0 / 12 | 0 / 25 | 0 / 15 |
Outcome results
Primary
Clinical Response of Success
The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.
Time frame: 28 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS1411 5 Min | Clinical Response of Success | 6 Participants |
| Placebo 5 Min | Clinical Response of Success | 4 Participants |
| DSXS1411 10 Min | Clinical Response of Success | 6 Participants |
| Placebo 10 Min | Clinical Response of Success | 1 Participants |
| DSXS1411 15 Min | Clinical Response of Success | 6 Participants |
| Placebo 15 Min | Clinical Response of Success | 1 Participants |
| DSXS1411 30 Min | Clinical Response of Success | 11 Participants |
| Placebo 30 Min | Clinical Response of Success | 1 Participants |
p-value: 0.3571Cochran-Mantel-Haenszel
p-value: 0.5224Cochran-Mantel-Haenszel
p-value: 0.389Cochran-Mantel-Haenszel
p-value: 0.0325Cochran-Mantel-Haenszel