Scalp Psoriasis
Conditions
Brief summary
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
Detailed description
This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp psoriasis
Interventions
DRUGDSXS
topical product
DRUGPlacebo
topical product
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
* Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization
Exclusion criteria
* Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed). * Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis) * Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study. * History of psoriasis unresponsive to topical treatments. * Current immunosuppression or history of organ transplant. * Patients who have a history of or current diagnosis of glaucoma. * Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan to have eye or eyelid surgery during the study. * Patients with active infection (including but not limited to bacterial, fungal and viral infection) and/or open wounds on the entire head and neck area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success in Patients With Moderate and Severe Scalp Psoriasis | from baseline to study day 29 | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline |
| Clinical Success in Patients With Mild to Severe Scalp Psoriasis | from baseline to study day 29 | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success in Patients With Mild Scalp Psoriasis | from baseline to study day 29 | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSXS 1535 DSXS 1535 topical product
DSXS: topical product | 183 |
| Placebo Vehicle
Placebo: topical product | 189 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Non-Compliance With Study Drug | 0 | 1 |
| Overall Study | Progressive Disease | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | DSXS 1535 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 17.2 | 48.1 years STANDARD_DEVIATION 17.3 | 48.1 years STANDARD_DEVIATION 17.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 77 Participants | 85 Participants | 162 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 104 Participants | 210 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 | 27 Participants | 29 Participants | 56 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis <= 3 Months | 2 Participants | 2 Participants | 4 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis >3 Months And <= 6 Months | 1 Participants | 1 Participants | 2 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis > 3 Years And <= 5 Years | 29 Participants | 28 Participants | 57 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis > 5 Years | 116 Participants | 118 Participants | 234 Participants |
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis > 6 Months And <= 1 Year | 8 Participants | 11 Participants | 19 Participants |
| Percent Scalp Affected | 32.4 percent STANDARD_DEVIATION 26.6 | 33.5 percent STANDARD_DEVIATION 25.3 | 33.0 percent STANDARD_DEVIATION 25.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 14 Participants | 31 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 159 Participants | 165 Participants | 324 Participants |
| Sex: Female, Male Female | 107 Participants | 118 Participants | 225 Participants |
| Sex: Female, Male Male | 76 Participants | 71 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 180 | 0 / 189 |
| other Total, other adverse events | 46 / 180 | 43 / 189 |
| serious Total, serious adverse events | 0 / 180 | 0 / 189 |
Outcome results
Primary
Clinical Success in Patients With Mild to Severe Scalp Psoriasis
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Time frame: from baseline to study day 29
Population: Patients with mild to severe scalp psoriasis (primary analysis 2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS 1535 | Clinical Success in Patients With Mild to Severe Scalp Psoriasis | 51 Participants |
| Placebo | Clinical Success in Patients With Mild to Severe Scalp Psoriasis | 50 Participants |
p-value: 0.8096Cochran-Mantel-Haenszel
Primary
Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Time frame: from baseline to study day 29
Population: Patients with moderate and severe scalp psoriasis (primary analysis 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS 1535 | Clinical Success in Patients With Moderate and Severe Scalp Psoriasis | 41 Participants |
| Placebo | Clinical Success in Patients With Moderate and Severe Scalp Psoriasis | 43 Participants |
p-value: 0.4557Cochran-Mantel-Haenszel
Secondary
Clinical Success in Patients With Mild Scalp Psoriasis
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Time frame: from baseline to study day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS 1535 | Clinical Success in Patients With Mild Scalp Psoriasis | 10 Participants |
| Placebo | Clinical Success in Patients With Mild Scalp Psoriasis | 7 Participants |
p-value: 0.7652Cochran-Mantel-Haenszel