Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib

Paronychia Clinical Trial

Official title:

A Clinical Study on the Treatment of Paronychia Caused by Afatinib With Zanthoxylum Nitidum Tincture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03908892
• Other study ID #: 2019KT1122
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Yanjuan Zhu, Dr
• Phone: 86 20 81887233
• Email: zyjsophy[@]gzucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Pathologically or cytologically confirmed non-small cell lung cancer;

2. Undergoing treatment with afatinib;

3. With grade 1 paronychia;

4. Age between 18 to 80 years old;

5. Estimated life expectancy of more than months;

6. With the written informed consent.

Exclusion Criteria:

1. Paronychia before afatinib treatment;

2. Grade 2 or severer paronychia;

3. Stop using afatinib or with reduced dose of afatinib;

4. Currently diagnosed with severe encephalopathy or psychiatric disorders affecting patients ability of self expression.

5. Has other legal, medical or ethical reasons that patients are not appropriate for clinical study.

Related Conditions & MeSH terms

• Paronychia

Intervention

Drug:
• zanthoxylum nitidum tincture
Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.
• tetracycline ointment
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to paronychia progress	The time elapsed from randomization to either the date of grade 2 or more paronychia occurrence, treatment completion, or last follow-up information. Frequency of evaluation for paronychia will be everyday.	Through study completion, an average of 10 days.
Secondary	Time to paronychia relief	The time elapsed from randomization to either the date of paronychia relief, treatment completion, or last follow-up information. Paronychia relief is defined as that paronychia disappears. Frequency of evaluation for paronychia will be everyday.	Through study completion, an average of 10 days.