Topical ointment for treating mild to moderate atopic dermatitis in adults
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
This study is testing a new ointment for adults with mild to moderate atopic dermatitis to see if it helps improve their skin condition compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hangzhou Yirui Pharmaceutical Technology Co., Ltd Industry-sponsored |
| Locations | 4 sites (Boynton Beach, Florida and 3 other locations) |
| Trial ID | NCT06309355 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of YR001, a topical ointment, in adult patients suffering from mild to moderate atopic dermatitis. Participants will be randomly assigned to receive either the YR001 ointment or a placebo. The study aims to determine how well the ointment works and its effects on the skin condition over the course of the trial. The research will involve assessments of the participants' skin condition and overall health throughout the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with mild to moderate atopic dermatitis and a BMI between 18.0 and 30.0.
Not a fit: Patients with severe skin conditions, infections, or those who have recently participated in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing symptoms of atopic dermatitis in adults.
How similar studies have performed: Other studies have shown promise with topical treatments for atopic dermatitis, but the specific approach with YR001 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boynton Beach, Florida and 3 other locations
- Encore Medical Research -Boynton Beach — Boynton Beach, Florida, United States (Recruiting)
- Encore Medical Research-Hollywood — Hollywood, Florida, United States (Recruiting)
- Encore Medical Research-Weston — Weston, Florida, United States (Recruiting)
- DelRicht Research — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Kevin Wei, Doctor
- Email: kai.wei@yirui-pharma.com
- Phone: +8618201496205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.