NCT04243486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

January 20, 2020

Last Update Submit

July 7, 2020

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

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

    Days 8, 15, and 29

  • Change in Percentage of scalp affected by psoriasis

    Days 8, 15, and 29

  • Percentage of subjects with pruritus severity score treatment success

    Days 8, 15, and 29

Study Arms (2)

UHE-105 Shampoo

EXPERIMENTAL

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

Drug: UHE-105

Vehicle Shampoo

PLACEBO COMPARATOR

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

Drug: Vehicle

Interventions

UHE-105DRUG

Topical shampoo containing active drug

UHE-105 Shampoo
VehicleDRUG

Topical shampoo containing no active drug

Vehicle Shampoo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

01

San Diego, California, 92123, United States

Location

02

High Point, North Carolina, 27262, United States

Location

Study Officials

  • Tony Andrasfay

    Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 28, 2020

Study Start

January 2, 2020

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)