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Completed

NCT Number: NCT04243486

A 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

01, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UHE-105

Drug

Topical shampoo containing active drug

Vehicle

Drug

Topical shampoo containing no active drug

Primary outcomes

  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 outcomes

  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 using an 11-point numeric rating scale (0-10)

Sponsors and collaborators

Lead sponsor

Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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