Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06309355

Enrollment

Registered

2024-03-13

Start date

2024-06-19

Completion date

2025-11-20

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

YR001, KV1.3

Brief summary

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis

Interventions

DRUGYR001 ointment

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50.	Day1-Day 50	incidence of treatment related AEs (TRAEs)

Secondary

Measure	Time frame	Description
all treatment-emergents AEs	Day1-Day 50	number, severity, causality, and outcome of all treatment-emergetns AEs (TEAEs)
Efficacy of YR001 Ointment	Day1-Day50	Proportion of patients achieving ISGA 0 or 1 by visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026