NCT06364969

Brief Summary

This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP). In this study, a combination of skin application and needle-free subcutaneous injection was used to investigate whether human endogenous molecules can cause itching. And a questionnaire is used to quantify the intensity of different candidates-induced itch.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

April 10, 2024

Last Update Submit

April 14, 2024

Conditions

CholestasisIntrahepatic Cholestasis of Pregnancy

Keywords

cholestasispruritus

Outcome Measures

Primary Outcomes (1)

  • Itch intensity

    by questionnaire

    Half an hour after receiving the injection

Secondary Outcomes (1)

  • Flare areas

    Half an hour after receiving the injection

Study Arms (1)

Healthy subjects

Healthy adult volunteers (aged 18-35 years)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Both male and female Healthy adult volunteers (aged 18-35 years)

You may qualify if:

  • Healthy adult volunteers

You may not qualify if:

  • People with mental disorders, bone or skeletal muscle disorders, psychological disorders, various skin diseases, allergic symptoms, and similar medical histories
  • People with itching or pain symptoms
  • People who were on medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

  • Yu H, Zhao T, Liu S, Wu Q, Johnson O, Wu Z, Zhuang Z, Shi Y, Peng L, He R, Yang Y, Sun J, Wang X, Xu H, Zeng Z, Zou P, Lei X, Luo W, Li Y. MRGPRX4 is a bile acid receptor for human cholestatic itch. Elife. 2019 Sep 10;8:e48431. doi: 10.7554/eLife.48431.

    PMID: 31500698BACKGROUND

MeSH Terms

Conditions

CholestasisIntrahepatic Cholestasis of PregnancyPruritus

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yulong Li

    Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangyi Lan

CONTACT

8613176881226guangyi_lan@stu.pku.edu.cn

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

April 20, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Privacy and competition

Locations

CN(1)