YR001 Ointment for Eczema

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

36 Participants Needed

Trial Summary

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 YR001 ointment safe for use in humans?

The safety of tacrolimus ointment, which may be similar to YR001, has been studied in adults and children with eczema. Common side effects include skin burning and itching, but these are usually mild and decrease over time. Long-term studies show it is generally safe for use in treating eczema. ^{1 2 3 4 5}

What is the purpose of this trial?

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Sweden pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Antipruritic Effect of Qingpeng Ointment on the Localized Nonexudative Eczema. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events from Emollient Use in Eczema: A Restricted Review of Published Data. [2021]