NCT03908892

Brief Summary

This is a randomized control trial evaluating the efficacy of zanthoxylum nitidum tincture on preventing progression of paronychia caused by afatinib from grade 1 to grade 2/3. Enrolled participates will randomly receive original treatment or original treatment plus zanthoxylum nitidum tincture immersion of the sick nail(s).

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
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 12, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

3.5 years

First QC Date

February 21, 2019

Last Update Submit

August 11, 2022

Conditions

Paronychia

Keywords

ParonychiaZanthoxylum nitidum tinctureAfatinib

Outcome Measures

Primary Outcomes (1)

  • Paronychia progress rate

    Incidence of grade 2 or more paronychia during paronychia treatment period will be reported. This period will be from randomization till paronychia relief or progression. Frequency of evaluation for paronychia will be everyday.

    Through study completion, an average of 10 days.

Secondary Outcomes (2)

  • Time to paronychia progress

    Through study completion, an average of 10 days.

  • Time to paronychia relief

    Through study completion, an average of 10 days.

Study Arms (2)

Combination group

EXPERIMENTAL

Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, plus local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day, till paronychia relief or progression.

Drug: zanthoxylum nitidum tinctureDrug: tetracycline ointment

Control group

ACTIVE COMPARATOR

Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression.

Drug: tetracycline ointment

Interventions

zanthoxylum nitidum tinctureDRUG

Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.

Combination group
tetracycline ointmentDRUG

Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day

Combination groupControl group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically or cytologically confirmed non-small cell lung cancer；
  • Undergoing treatment with afatinib；
  • With grade 1 paronychia；
  • Age between 18 to 80 years old；
  • Estimated life expectancy of more than months；
  • With the written informed consent.

You may not qualify if:

  • Paronychia before afatinib treatment;
  • Grade 2 or severer paronychia;
  • Stop using afatinib or with reduced dose of afatinib;
  • Currently diagnosed with severe encephalopathy or psychiatric disorders affecting patients ability of self expression.
  • Has other legal, medical or ethical reasons that patients are not appropriate for clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Paronychia

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yanjuan Zhu, Dr

CONTACT

86 20 81887233zyjsophy@gzucm.edu.cn

Yihong Liu, Dr

CONTACT

80 20 81887233yihongl@gzucm.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2019

First Posted

April 9, 2019

Study Start

June 12, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)