Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis
Conditions:
Atopic Dermatitis
Study Start (Actual) 2024-06-19
Primary Completion (Estimated) 2025-01-20
Study Completion (Estimated) 2025-06-20
Enrollment (Estimated) 36
Study Type INTERVENTIONAL
Phase PHASE2
Locations:
📍 Baton Rouge, Louisiana, United States

Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Written informed consent obtained from the subject.
    • 2. Male or female subject is aged 18 or older.
    • 3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
    • 4. An Investigator Static Global Assessment (ISGA) score of 2 (mild) to 3 (moderate) at screening and Baseline.

    Exclusion Criteria:

    • 1. Pregnant or lactating women.
    • 2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
    • 3. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
    • 4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.
    • 5. Participation in another interventional clinical trial (e.g. investigational drug, biological agent, or device) within 30 days or 5 half-lives of investigational agent (whichever is longer) before entering, or during the trial, or previous participation in this clinical trial.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2024-03-06
  • First Submitted that Met QC Criteria2024-03-06
  • First Posted2024-03-13

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-06-24
  • Last Update Posted2024-06-26
  • Last Verified2024-03