Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis

Description

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

Study Overview

Study Details

Study overview

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients 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

Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Baton Rouge

DelRicht Research, Baton Rouge, Louisiana, United States, 70809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hangzhou Yirui Pharmaceutical Technology Co., Ltd,

Study Record Dates

2025-06-20