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Topical Ointment

Part A, Active dose A and Low body surface area for Psoriasis

Phase 1
Waitlist Available
Research Sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 22
Awards & highlights

Study Summary

This trial tests a new topical ointment to see if it is safe, well-tolerated, and affects the body in expected ways.

Eligible Conditions
  • Psoriasis
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Safety and Maximum Tolerate Dose (MTD)
Part B: Safety and Maximum Tolerate Dose (MTD)
Secondary outcome measures
Part A: all treatment-emergent AEs
Part B: all treatment-emergent AEs

Trial Design

12Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B, Active dose B and High body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration
Group II: Part B, Active dose A and High body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration
Group III: Part A, Active dose B and Middle body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration
Group IV: Part A, Active dose B and Low body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration
Group V: Part A, Active dose B and High body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration
Group VI: Part A, Active dose A and Middle body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration
Group VII: Part A, Active dose A and Low body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration
Group VIII: Part A, Active dose A and High body surface areaExperimental Treatment1 Intervention
The intervention is YR001 Dose A on high body surface area, low dose for single topical administration
Group IX: Part A, Placebo and Low body surface areaPlacebo Group1 Intervention
The intervention is Placebo on low body surface area, Placebo for single topical administration
Group X: Part A, Placebo and Middle body surface areaPlacebo Group1 Intervention
The intervention is Placebo on middle body surface area, Placebo for single topical administration
Group XI: Part A, Placebo and High body surface areaPlacebo Group1 Intervention
The intervention is Placebo on high body surface area, Placebo for single topical administration
Group XII: Part B, Placebo and High body surface areaPlacebo Group1 Intervention
The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
YR001 Dose A on low body surface area
2023
Completed Phase 1
~60
YR001 Dose A on middle body surface area
2023
Completed Phase 1
~60
YR001 Dose A on high body surface area
2023
Completed Phase 1
~60
YR001 Dose B on low body surface area
2023
Completed Phase 1
~60
YR001 Dose B on middle body surface area
2023
Completed Phase 1
~60
YR001 Dose B on high body surface area
2023
Completed Phase 1
~60
YR001 Dose A on high body surface area twice daily
2023
Completed Phase 1
~60
YR001 Dose B on high body surface area twice daily
2023
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hangzhou Yirui Pharmaceutical Technology Co., LtdLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Stacy Smith, Dr. MDStudy DirectorEncinitas, California USA

Media Library

YR001 (Topical Ointment) Clinical Trial Eligibility Overview. Trial Name: NCT05718921 — Phase 1
Psoriasis Research Study Groups: Part A, Active dose A and Low body surface area, Part A, Active dose A and Middle body surface area, Part A, Active dose A and High body surface area, Part A, Active dose B and Low body surface area, Part A, Active dose B and Middle body surface area, Part A, Active dose B and High body surface area, Part A, Placebo and Low body surface area, Part A, Placebo and Middle body surface area, Part A, Placebo and High body surface area, Part B, Active dose A and High body surface area, Part B, Active dose B and High body surface area, Part B, Placebo and High body surface area
Psoriasis Clinical Trial 2023: YR001 Highlights & Side Effects. Trial Name: NCT05718921 — Phase 1
YR001 (Topical Ointment) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05718921 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for enrolling in this trial?

"This study seeks 54 participants suffering from atopic dermatitis between the age of majority and 65."

Answered by AI

Does the criteria for this medical experiment preclude individuals over 85 years of age?

"Participants of this medical trial must be between 18 and 65 years old to meet the study's eligibility requirements."

Answered by AI

What has been determined regarding the safety of Part A, Active dose A and High body surface area for individuals?

"Power's team gave Part A, Active dose A and High body surface area a score of 1 due to the minimal data available in relation to its efficacy and safety. This is only Phase 1 trial after all."

Answered by AI

How many participants is this experiment enrolling?

"Affirmative. Analysis of the data hosted on clinicaltrials.gov reveals that this medical trial is presently enrolling participants, beginning from April 8th 2023 and last updated May 24th 2023. 54 patients are being recruited across a single site."

Answered by AI

Is this study looking for new participants at present?

"Indeed, the information published on clinicaltrials.gov reflects that this medical study is actively recruiting participants; it was first shared online on April 8th 2023 and updated May 24th of the same year. 54 volunteers are required to complete this trial at one research site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers
2023. "A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05718921.
~27 spots leftby Apr 2025
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