Clinical trial NCT04243486: A Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scalp Psoriasis
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Investigator's Global Assessment (IGA) Treatment Success
timeFrame: Day 15
measure: Investigator's Global Assessment (IGA) Treatment Success
timeFrame: Day 29
Secondary outcomes:
measure: Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success
timeFrame: Days 8, 15, and 29
measure: Change in Percentage of scalp affected by psoriasis
timeFrame: Days 8, 15, and 29
measure: Percentage of subjects with pruritus severity score treatment success
timeFrame: Days 8, 15, and 29
Other outcomes:
Locations:
city: San Diego
country: United States
facility: 01
state: California
city: High Point
country: United States
facility: 02
state: North Carolina
Study officials:
affiliation: Therapeutics, Inc.
name: Tony Andrasfay
role: STUDY_DIRECTOR
References: