Scalp Psoriasis
Conditions
Brief summary
This study is to compare the safety and efficacy of UHE-105 Shampoo with that of the vehicle (VEH) Shampoo in subjects with scalp psoriasis. Half of the subjects will receive the UHE-105 Shampoo, while the other half will receive the VEH Shampoo with no active drug.
Interventions
DRUGUHE-105
Topical shampoo containing active drug
DRUGVehicle
Topical shampoo containing no active drug
Sponsors
Therapeutics, 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
* Subject is a male or non-pregnant female 18 years of age or older. * Subject has provided written informed consent. * Females must be post-menopausal , surgically sterile or use an effective method of birth control. , Women of childbearing potential must have a negative urine pregnancy test at Visit 1/Baseline. * Subject has a clinical diagnosis of stable moderate to severe scalp psoriasis affecting at least 10% of the scalp. * Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. * Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of scalp psoriasis or exposes the subject to an unacceptable risk by study participation.
Exclusion criteria
* Subject is pregnant, lactating, or is planning to become pregnant during the study. * Subject has spontaneously improving or rapidly deteriorating scalp psoriasis. * Subject has guttate, pustular, erythrodermic, or other non-plaque forms of scalp psoriasis. * Subject has any physical condition which, in the investigator's opinion, could impair evaluation of scalp psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome), or which exposes the subject to an unacceptable risk by study participation. * Subject has scalp psoriasis that necessitates systemic or other concomitant topical therapies during the study. * Subject has a history of psoriasis unresponsive to topical treatments. * Subject has any hair on their scalp of a length that extends beyond the subject's chin. * Subject has any open sores, lesions, cuts, or infections, etc. on the scalp or has had a scalp surgical procedure within the past 30 days. * Subject is currently enrolled in an investigational drug or device study. Other protocol defined inclusion or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) Treatment Success | Day 15 | The percentage of subjects classified as IGA treatment success |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success | Days 8, 15, and 29 | Percentage of subjects classified as treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) |
| Change in Percentage of scalp affected by psoriasis | Days 8, 15, and 29 | Change from baseline in the percentage of scalp affected by psoriasis |
| Percentage of subjects with pruritus severity score treatment success | Days 8, 15, and 29 | Percentage of subjects classified as treatment success for change from baseline in pruritus severity score using an 11-point numeric rating scale (0-10) |
Countries
United States
Outcome results
None listed