Paronychia
Conditions
Keywords
Paronychia, Zanthoxylum nitidum tincture, Afatinib
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).
Interventions
DRUGzanthoxylum nitidum tincture
Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day
Sponsors
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paronychia progress rate | Through study completion, an average of 10 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to paronychia progress | Through study completion, an average of 10 days. | 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. |
| Time to paronychia relief | Through study completion, an average of 10 days. | 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. |
Countries
China
Contacts
Primary ContactYanjuan Zhu, Dr
Backup ContactYihong Liu, Dr
Outcome results
None listed