Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib

NCT03908892 — Not applicable, Unknown, 110 participants, Guangzhou University of Traditional Chinese Medicine

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

Registry	NCT03908892
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	110 (Estimated)
Sponsor	Guangzhou University of Traditional Chinese Medicine (Other)
Conditions	Paronychia
Interventions	zanthoxylum nitidum tincture, tetracycline ointment (Drug)
Dates	start 2019-06-12, primary completion 2022-12-01 (estimated), completion 2022-12-01 (estimated), first posted 2019-04-09, last updated 2022-08-15
Locations	1 site in China

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Combination group	Experimental	Drug: zanthoxylum nitidum tincture; Drug: tetracycline ointment	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.
Control group	Active comparator	Drug: tetracycline ointment	Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression.

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

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

Facility	City	Country	Status
Guangdong Provincial Hospital of Chinese Medicine	Guangzhou, Guangdong	China	Recruiting