Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis

NCT ID: NCT06309355

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-19

Study Completion Date

2025-11-20

Brief Summary

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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

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Conditions

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Atopic Dermatitis

Keywords

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YR001 KV1.3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active dose

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

Group Type EXPERIMENTAL

YR001 ointment

Intervention Type DRUG

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

Placebo dose

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

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

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

Interventions

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YR001 ointment

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hangzhou Yirui Pharmaceutical Technology Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Encore Medical Research -Boynton Beach

Boynton Beach, Florida, United States

Site Status

Encore Medical Research-Hollywood

Hollywood, Florida, United States

Site Status

Encore Medical Research-Weston

Weston, Florida, United States

Site Status

DelRicht Research

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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YR001-A03

Identifier Type: -

Identifier Source: org_study_id