A Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis

Conditions
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Scalp Psoriasis

Intervention / Treatment
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* Drug: UHE-105
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria assessed by the study staff may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UHE-105 Shampoo<br>UHE-105 Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks | Drug: UHE-105<br>* Topical shampoo containing active drug<br>|
| Placebo Comparator: Vehicle Shampoo<br>Vehicle Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks | Drug: Vehicle<br>* Topical shampoo containing no active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) Treatment Success | The percentage of subjects classified as IGA treatment success | Day 15 | 
| Investigator's Global Assessment (IGA) Treatment Success | The percentage of subjects classified as IGA treatment success | Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success | Percentage of subjects classified as treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) | Days 8, 15, and 29 | 
| Change in Percentage of scalp affected by psoriasis | Change from baseline in the percentage of scalp affected by psoriasis | Days 8, 15, and 29 | 
| Percentage of subjects with pruritus severity score treatment success | Percentage of subjects classified as treatment success for change from baseline in pruritus severity score using an 11-point numeric rating scale (0-10) | Days 8, 15, and 29 |