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

Primary Purpose

Scalp Psoriasis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

UHE-105

Vehicle

About this trial

This is an interventional treatment trial for Scalp Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

UHE-105 Shampoo

Vehicle Shampoo

Arm Description

UHE-105 Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks

Vehicle Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks

Outcomes

Primary Outcome Measures

Investigator's Global Assessment (IGA) Treatment Success

The percentage of subjects classified as IGA treatment success

Investigator's Global Assessment (IGA) Treatment Success

The percentage of subjects classified as IGA treatment success

Secondary Outcome Measures

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)

Change in Percentage of scalp affected by psoriasis

Change from baseline in the percentage of scalp affected by psoriasis

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)

Full Information

NCT ID

NCT04243486

First Posted

January 20, 2020

Last Updated

July 7, 2020

Sponsor

Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04243486

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

January 2, 2020 (Actual)

Primary Completion Date

June 15, 2020 (Actual)

Study Completion Date

June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scalp Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UHE-105 Shampoo

Arm Type

Experimental

Arm Description

UHE-105 Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks

Arm Title

Vehicle Shampoo

Arm Type

Placebo Comparator

Arm Description

Vehicle Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks

Intervention Type

Drug

Intervention Name(s)

UHE-105

Intervention Description

Topical shampoo containing active drug

Intervention Type

Drug

Intervention Name(s)

Vehicle

Intervention Description

Topical shampoo containing no active drug

Primary Outcome Measure Information:

Title

Investigator's Global Assessment (IGA) Treatment Success

Description

The percentage of subjects classified as IGA treatment success

Time Frame

Day 15

Title

Investigator's Global Assessment (IGA) Treatment Success

Description

The percentage of subjects classified as IGA treatment success

Time Frame

Day 29

Secondary Outcome Measure Information:

Title

Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success

Description

Percentage of subjects classified as treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)

Time Frame

Days 8, 15, and 29

Title

Change in Percentage of scalp affected by psoriasis

Description

Change from baseline in the percentage of scalp affected by psoriasis

Time Frame

Days 8, 15, and 29

Title

Percentage of subjects with pruritus severity score treatment success

Description

Percentage of subjects classified as treatment success for change from baseline in pruritus severity score using an 11-point numeric rating scale (0-10)

Time Frame

Days 8, 15, and 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tony Andrasfay

Organizational Affiliation

Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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