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

Scalp Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243486
• Other study ID #: 188-0552-202
• Status: Completed
• Phase: Phase 2
• Start date: January 2, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: July 2020
• Source: Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• UHE-105
Topical shampoo containing active drug
• Vehicle
Topical shampoo containing no active drug

Locations

Country	Name	City	State
United States	02	High Point	North Carolina
United States	01	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Global Assessment (IGA) Treatment Success	The percentage of subjects classified as IGA treatment success	Day 15
Primary	Investigator's Global Assessment (IGA) Treatment Success	The percentage of subjects classified as IGA treatment success	Day 29
Secondary	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
Secondary	Change in Percentage of scalp affected by psoriasis	Change from baseline in the percentage of scalp affected by psoriasis	Days 8, 15, and 29
Secondary	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