YR001 Ointment for Eczema
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Disqualifiers: Pregnant, Skin damage, Skin disease, others
No Placebo Group
Prior Safety Data
Trial Summary
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
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.
12345Eligibility 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
I am 18 years old or older.
Written informed consent obtained from the subject
I weigh at least 50 kg and my BMI is between 18.0 and 30.0.
+1 more
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
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Placebo doseExperimental Treatment2 Interventions
The intervention is Placebo on a range of body surface area for multiple topical administration
Group II: Active doseExperimental Treatment1 Intervention
The intervention is YR001 ointment on a range of body surface area for multiple topical administration
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Encore Medical Research -Boynton BeachBoynton Beach, FL
Encore Medical Research-HollywoodHollywood, FL
Encore Medical Research-WestonWeston, FL
DelRicht ResearchBaton Rouge, LA
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Who Is Running the Clinical Trial?
Hangzhou Yirui Pharmaceutical Technology Co., LtdLead Sponsor
References
The efficacy and safety of tacrolimus ointment: a clinical review. [2013]Topical tacrolimus ointment was approved for the treatment of atopic dermatitis in Japan in 1999, the United States in 2000, and Europe in 2001. The safety and efficacy of tacrolimus ointment was established in vehicle-controlled, randomized, 12-week clinical trials; 1-year open-label trials; and comparative studies with topical steroids. Although an extensive database exists on the safety and efficacy of tacrolimus ointment based on the global development program, clinicians desire additional information on the long-term safety and efficacy of this novel agent. In this supplement, additional studies are reported that extend the safety and efficacy profile of tacrolimus ointment in patients with atopic dermatitis, including long-term safety studies for up to 4 years. The studies presented in this supplement address important questions regarding the selection and use of tacrolimus ointment in the treatment of patients with atopic dermatitis.
Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. [2013]Tacrolimus ointment is a topical calcineurin inhibitor for the treatment of atopic dermatitis. The primary objective of this open-label study was to assess the long-term safety of tacrolimus ointment. The primary end-point was the incidence of adverse events. Secondary end-points included the Eczema Area and Severity Index and a modified version of this index. A total of 466 children with atopic dermatitis, aged 2-15 years, applied 0.03% or 0.1% tacrolimus ointment twice daily for up to 29.5 months. Skin burning and pruritus were the most common application site events; their prevalence decreased over time. There was no increase in viral infections or other adverse events over time. Laboratory profiles were consistent with those reported in atopic populations. Substantial improvement in all efficacy end-points was observed by week 2 and maintained throughout the study. Long-term treatment with tacrolimus ointment is safe and effective in these patients with atopic dermatitis.
Antipruritic Effect of Qingpeng Ointment on the Localized Nonexudative Eczema. [2022]To evaluate the effectiveness and safety of Qingpeng ointment on eczema-associated pruritus.
Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. [2022]In two randomized, double-blind, multicenter studies, a total of 631 adult patients with moderate to severe atopic dermatitis applied tacrolimus ointment (0.03% or 0.1%) or vehicle twice daily for up to 12 weeks. The mean percent body surface area (%BSA) affected at baseline was 45%, and 56% of patients had severe atopic dermatitis. As previously reported, these studies showed that tacrolimus ointment was superior to vehicle for all efficacy parameters measured. This report focuses on the safety of tacrolimus ointment in these studies. The most common adverse events were the sensation of skin burning, pruritus, flu-like symptoms, skin erythema, and headache. Skin burning and pruritus were more common among patients with severe or extensive disease; these events were usually brief and were resolved during the first few days of treatment. Common adverse events with a significantly higher incidence in one or both of the tacrolimus ointment groups than in the vehicle group included skin burning, flu-like symptoms, and headache. More patients in the vehicle group discontinued the study because of an adverse event than in either of the tacrolimus ointment groups. There were no notable or consistent changes in any laboratory variables. Tacrolimus was not detected in 80% of blood samples collected. Measurable concentrations of tacrolimus were transitory and were not associated with adverse events. Tacrolimus ointment is a safe therapy for the treatment of adult patients with atopic dermatitis on the face, neck, or other body regions.
Adverse Events from Emollient Use in Eczema: A Restricted Review of Published Data. [2021]Atopic dermatitis/eczema is a chronic inflammatory skin condition, and emollients are the first-line treatment. Despite their widespread use, there is uncertainty about the frequency and type of adverse events associated with different emollients. We conducted a restricted review of published data on adverse events associated with emollient use in eczema. Medline (Ovid) was searched from inception (1946) to June 2018. All types of studies, with the exception of reviews, were included. Eligibility was assessed using a two-stage screening process against inclusion and exclusion criteria. References of all included papers were screened for any additional eligible papers. Data were subsequently extracted from all eligible publications. A limited body of data were found in the published data: 24 papers reported on adverse events with 29 different emollients (3 containing urea, 5 containing ceramide, 4 containing glycerol, 4 were herbal and 13 contained "other" ingredients). Interpretation of the results and comparison of the emollients were difficult due to poor reporting and missing data. Many publications contained no data at all on adverse events, and no study reported serious treatment-related adverse events for any emollient. The proportion of participants in the studies experiencing treatment-related adverse events varied between 2 and 59%. The most common adverse events were skin related and often mild. The range of participants experiencing non-treatment-related adverse events varied between 4 and 43%. From this restricted review, clinicians and patients can be reassured that the emollients studied appear to be generally safe to use. Better studies and reporting of adverse events associated with emollients in common use are needed.