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OpenTrials
Completed

NCT Number: NCT06309355

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Encore Medical Research -Boynton Beach, Boynton Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Pregnant or lactating women.
  • Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
  • Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
  • 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.
  • 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.

Treatment and study plan

YR001 ointment

Drug

The intervention is YR001 ointment on a range of body surface area for multiple topical administration

Placebo

Other

The intervention is Placebo on a range of body surface area for multiple topical administration

Primary outcomes

  1. The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50.

    Time frame: Day1-Day 50

    incidence of treatment related AEs (TRAEs)

Secondary outcomes

  1. all treatment-emergents AEs

    Time frame: Day1-Day 50

    number, severity, causality, and outcome of all treatment-emergetns AEs (TEAEs)

  2. Efficacy of YR001 Ointment

    Time frame: Day1-Day50

    Proportion of patients achieving ISGA 0 or 1 by visit

Sponsors and collaborators

Lead sponsor

Hangzhou Yirui Pharmaceutical Technology Co., Ltd

Industry

Registry information

Official study title

A Randomized, Placebo-controlled, Double-blind, Multi Center, Phase IIa Trial Investigating the Safety, Tolerability, Pharmacokinetics and Efficacy of Topical Ointment YR001 in Adult Patients With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2024
Registry last updated
Dec 18, 2025

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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