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

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

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.

Study Overview

• Status: Completed
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: UHE-105; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • 01
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • 02

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Therapeutics, Inc.
• Investigators: Study Director: Tony Andrasfay, Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 188-0552-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No