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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04243486
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tony Andrasfay
Principal Investigator Affiliation Therapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scalp Psoriasis
Arms & Interventions

Arms

Experimental: UHE-105 Shampoo

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

Placebo Comparator: Vehicle Shampoo

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

Interventions

Drug: - UHE-105

Topical shampoo containing active drug

Drug: - Vehicle

Topical shampoo containing no active drug

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

01, San Diego, California

Status

Recruiting

Address

01

San Diego, California, 92123

02, High Point, North Carolina

Status

Recruiting

Address

02

High Point, North Carolina, 27262

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