Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib

Study Overview
=================
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).

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

Conditions
-----------------
Paronychia

Intervention / Treatment
-----------------
* Drug: zanthoxylum nitidum tincture
* Drug: tetracycline ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paronychia, Zanthoxylum nitidum tincture, Afatinib