Topical YR001 Ointment in Adult with Mild to Moderate Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Other: Placebo; Drug: YR001 ointment

• Registration Number: NCT06309355
• Lead Sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-13
• Study Start: 2024-06-19
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo dose	Placebo	The intervention is Placebo on a range of body surface area for multiple topical administration
Active dose	YR001 ointment	The intervention is YR001 ointment on a range of body surface area for multiple topical administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Encore Medical Research -Boynton Beach; 🇺🇸 Boynton Beach, Florida, United States

Encore Medical Research-Hollywood; 🇺🇸 Hollywood, Florida, United States

Encore Medical Research-Weston; 🇺🇸 Weston, Florida, United States

DelRicht Research; 🇺🇸 Baton Rouge, Louisiana, United States