Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib

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

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).

Study Overview

• Status: Recruiting
• Conditions: Paronychia
• Intervention / Treatment: Drug: zanthoxylum nitidum tincture; Drug: tetracycline ointment

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanjuan Zhu, Dr; Phone Number: 34830 86 20 81887233; Email: zyjsophy@gzucm.edu.cn
• Study Contact Backup: Name: Yihong Liu, Dr; Phone Number: 34830 80 20 81887233; Email: yihongl@gzucm.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangdong Provincial Hospital of Chinese Medicine
      • Contact: Yanjuan Zhu, Dr.; Phone Number: 34830 86 20 81887233; Email: zyjsophy@gzucm.edu.cn
      • Contact: Yihong Liu, Dr.; Phone Number: 34830 86 20 81887233; Email: yihongl@gzucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination group; 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 tincture; Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.; Drug: tetracycline ointment; Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day
Active Comparator: Control group; Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression.	Drug: tetracycline ointment; Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: April 7, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Afatinib; Paronychia; Zanthoxylum nitidum tincture
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Skin Diseases, Infectious; Nail Diseases; Paronychia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Tetracycline
• Other Study ID Numbers: 2019KT1122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No