Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis

NCT06309355 | Completed Phase 2 FDA Drug

• 1 other identifier: YR001-A03
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

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

Conditions

Atopic Dermatitis

Keywords

YR001; KV1.3

Outcome Measures

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.

  incidence of treatment related AEs (TRAEs)

  Day1-Day 50

Secondary Outcomes (2)

• all treatment-emergents AEs

  Day1-Day 50

• Efficacy of YR001 Ointment

  Day1-Day50

Study Arms (2)

Active dose

EXPERIMENTAL

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

Drug: YR001 ointment

Placebo dose

EXPERIMENTAL

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

Other: Placebo

Interventions

YR001 ointment DRUG

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

Active dose

Placebo OTHER

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

Placebo dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Yirui Pharmaceutical Technology Co., Ltd: lead

Study Sites (4)

Encore Medical Research -Boynton Beach

Boynton Beach, Florida, 33436, United States

Location

Encore Medical Research-Hollywood

Hollywood, Florida, 33331, United States

Location

Encore Medical Research-Weston

Weston, Florida, 33331, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: June 19, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)