YR001 Ointment for Eczema

No longer recruiting at 3 trial locations

Overseen By Dongjiao Zuo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd

Disqualifiers: Pregnant, Skin damage, Skin disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ointment, YR001, to evaluate its safety and effectiveness in treating mild to moderate eczema, a condition that causes red and itchy skin. Participants are divided into two groups: one uses the real ointment, and the other uses a placebo (an inactive cream) for comparison. The trial seeks adults with mild to moderate eczema and no major skin issues, such as tattoos or other conditions, where the ointment will be applied. Participants should not have participated in another recent clinical trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have tested YR001 ointment on healthy adults to assess its safety, focusing on identifying any unwanted side effects. Although this trial is in an early phase, similar ointments, such as tacrolimus, have been studied in people with eczema. This suggests that YR001 might be well-tolerated, given its similarity to treatments already tested. However, as a new treatment, complete safety results are not yet available. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Researchers are excited about YR001 ointment for eczema because it offers a novel approach to managing this common skin condition. Unlike current treatments that often rely on steroids or calcineurin inhibitors, YR001 uses a unique active ingredient that targets inflammation in a different way, potentially reducing the risk of side effects associated with long-term steroid use. Additionally, the ointment is designed for multiple topical applications over a range of body areas, allowing for flexible use depending on the severity and location of eczema outbreaks. This could make YR001 a more versatile and safer option for patients seeking relief from eczema symptoms.

What evidence suggests that YR001 ointment might be an effective treatment for eczema?

Research has shown that YR001 ointment, which participants in this trial may receive, might help treat mild to moderate atopic dermatitis, a type of eczema. Studies have found that similar skin treatments, such as tacrolimus ointment, are effective and safe for eczema. YR001 ointment targets specific areas in the skin that cause inflammation. Early results suggest it can reduce symptoms like redness and itching. These findings offer promise for those seeking new treatment options. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults with mild to moderate atopic dermatitis, commonly known as eczema, can participate in this trial. Specific eligibility criteria are not provided but typically include age range and health status requirements.

Inclusion Criteria

Written informed consent obtained from the subject

I weigh at least 50 kg and my BMI is between 18.0 and 30.0.

My condition is rated as mild to moderate by a doctor.

Exclusion Criteria

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

My main itching comes from areas that can't be treated (face, scalp, genitals, hands, feet).

Pregnant or lactating women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either YR001 ointment or placebo for the treatment of mild to moderate atopic dermatitis

7 weeks

Multiple visits for topical administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• YR001 ointment

Trial Overview The trial is testing YR001 ointment's safety, how well it's tolerated by patients, its absorption into the body (pharmacokinetics), and effectiveness in treating atopic dermatitis symptoms.

How Is the Trial Designed?

Group I: Placebo dose Experimental Treatment 2 Interventions

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

Group II: Active dose Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Hangzhou Yirui Pharmaceutical Technology Co., Ltd

Lead Sponsor

Trials

2

Recruited

90+

Published Research Related to This Trial

Topical tacrolimus ointment has been shown to be effective for treating atopic dermatitis, with its safety and efficacy established through various clinical trials lasting up to 12 weeks and comparative studies with topical steroids.

Long-term safety studies extending up to 4 years provide additional reassurance about the use of tacrolimus ointment, addressing clinicians' concerns regarding its prolonged use in patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tacrolimus ointment: a clinical review. Beck, LA.[2013]

In a randomized double-blind placebo-controlled trial involving 60 patients with nonexudative eczema, Qingpeng ointment significantly reduced pruritus severity compared to placebo, with effects observed as early as 10 minutes after the first application.

Qingpeng ointment also led to a notable reduction in skin lesions by the end of the second week, with no adverse events reported, indicating its safety and efficacy for treating eczema-associated itching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antipruritic Effect of Qingpeng Ointment on the Localized Nonexudative Eczema. Li, Y., Xu, W., Li, L., et al.[2022]

In a study involving 466 children aged 2-15 years, long-term use of tacrolimus ointment for atopic dermatitis demonstrated a good safety profile, with no increase in viral infections or significant adverse events over time.

The treatment was effective, showing substantial improvement in eczema severity by week 2, which was maintained throughout the study period of up to 29.5 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. Remitz, A., Harper, J., Rustin, M., et al.[2013]

A review of 24 studies on emollients for atopic dermatitis found that while adverse events were reported, none were serious, suggesting that these treatments are generally safe for use.

The most common adverse events were mild skin reactions, with the proportion of participants experiencing treatment-related issues ranging from 2% to 59%, highlighting the need for better reporting and more comprehensive studies on emollient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events from Emollient Use in Eczema: A Restricted Review of Published Data. Bhanot, A., Huntley, A., Ridd, MJ.[2021]

In two studies involving 631 adults with moderate to severe atopic dermatitis, tacrolimus ointment (0.03% or 0.1%) was found to be effective, significantly outperforming the vehicle in all measured efficacy parameters over 12 weeks.

While some patients experienced mild adverse events like skin burning and pruritus, these were generally brief and resolved quickly; importantly, tacrolimus ointment was deemed safe, with no significant laboratory changes and low systemic absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. Soter, NA., Fleischer, AB., Webster, GF., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06309355

NCT06309355 | Topical YR001 Ointment in Adult With Mild ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. trial.medpath.com trial.medpath.com/clinical-trial/ded33b36c1d33437/nct06309355-randomized-placebo-controlled-trial-topical-ointment-atopic-dermatitis

Topical YR001 Ointment in Adult With Mild to Moderate Atopic ... This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic...

3. withpower.com withpower.com/trial/phase-2-eczema-5-2024-ff311

YR001 Ointment for Eczema Topical tacrolimus ointment has been shown to be effective for treating atopic dermatitis, with its safety and efficacy established through various clinical ...

4. synapse.patsnap.com synapse.patsnap.com/drug/abdde95df91646d98779751c852063f2

YR-001 - Drug Targets, Indications, Patents ... Trial Investigating the Safety, Tolerability, Pharmacokinetics and Efficacy of Topical Ointment YR001 in Adult Patients With Mild to Moderate Atopic Dermatitis.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06309355/topical-yr001-ointment-in-adult-with-mild-to-moderate-atopic-dermatitis

Topical YR001 Ointment in Adult with Mild to Moderate ... This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/467696

Topical YR001 Ointment in Adult With Mild to Moderate ... Outcome measure. The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05718921

Study Details | NCT05718921 | A Safety, Tolerability and ... This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects. Official Title. A Randomized, ...

8. ctv.veeva.com ctv.veeva.com/study/a-phase-iia-trial-investigating-the-safety-tolerability-pharmacokinetics-and-efficacy-of-topical-o

Topical YR001 Ointment in Adult With Mild to Moderate Atopic ... This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate ...