Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib

Guangzhou University of Traditional Chinese Medicine

Status: Enrolling

Conditions: Paronychia

Treatments: Drug: zanthoxylum nitidum tincture; Drug: tetracycline ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT03908892

2019KT1122

Details and patient eligibility

About

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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Combination group

Experimental group

Description:

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.

Treatment:

Drug: zanthoxylum nitidum tincture

Drug: tetracycline ointment

Control group

Active Comparator group

Description:

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

Treatment:

Drug: tetracycline ointment