Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243486
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: UHE-105 Drug: Vehicle Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : June 6, 2020
Estimated Study Completion Date : August 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) Treatment Success [ Time Frame: Day 15 ]
    The percentage of subjects classified as IGA treatment success

  2. Investigator's Global Assessment (IGA) Treatment Success [ Time Frame: Day 29 ]
    The percentage of subjects classified as IGA treatment success


Secondary Outcome Measures :
  1. Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success [ Time Frame: Days 8, 15, and 29 ]
    Percentage of subjects classified as treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)

  2. Change in Percentage of scalp affected by psoriasis [ Time Frame: Days 8, 15, and 29 ]
    Change from baseline in the percentage of scalp affected by psoriasis

  3. Percentage of subjects with pruritus severity score treatment success [ Time Frame: Days 8, 15, and 29 ]
    Percentage of subjects classified as treatment success for change from baseline in pruritus severity score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243486


Contacts
Layout table for location contacts
Contact: TI Clinical Operations 858-571-1800 ext 162 clinicalresearch@therapeuticsinc.com

Locations
Layout table for location information
United States, California
01 Recruiting
San Diego, California, United States, 92123
United States, North Carolina
02 Recruiting
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Tony Andrasfay Therapeutics, Inc.
Layout table for additonal information
Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04243486    
Other Study ID Numbers: 188-0552-202
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases