ParonychiaNCT03908892
Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib
A study testing zanthoxylum nitidum tincture and tetracycline ointment in people with Paronychia, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paronychia
- What is being tested?
- zanthoxylum nitidum tincture and tetracycline ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Yanjuan Zhu, Dr., 86 20 81887233 ext. 34830, zyjsophy@gzucm.edu.cn
Yihong Liu, Dr., 86 20 81887233 ext. 34830, yihongl@gzucm.edu.cn
About this study
Official title: 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).
- Conditions
- Paronychia
- Being tested
- zanthoxylum nitidum tincture, tetracycline ointment
- Keywords
- Paronychia, Zanthoxylum nitidum tincture, Afatinib
- Medical subject headings
- Paronychia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zanthoxylum nitidum tinctureDrug
Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.
tetracycline ointmentDrug
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Combination group | Experimental | 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. Receives: Drug: zanthoxylum nitidum tincture; Drug: tetracycline ointment |
| Control group | Active comparator | Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression. Receives: Drug: tetracycline ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 10 days.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start12 Jun 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParonychiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haibo Zhang, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908892
- Sponsor's protocol ID
- 2019KT1122
- Status last verified
- Aug 2022
- First submitted
- 21 Feb 2019
- Last updated
- 15 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Treatment of Paronychia Caused by Afatinib With Zanthoxylum Nitidum Tincture
- ClinicalTrials.gov ID
- NCT03908892
- Acronym / sponsor ID
- 2019KT1122
- Conditions
- Paronychia
- Keywords
- Paronychia, Zanthoxylum nitidum tincture, Afatinib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination group | Experimental | Drug: zanthoxylum nitidum tincture, Drug: tetracycline ointmentLocal 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 ointmentLocal use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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；
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zanthoxylum nitidum tinctureLocal application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day. | Drug | Combination group |
| tetracycline ointmentLocal use of 1% tetracycline ointment for the sick nail(s), 3 times a day | Drug | Combination group, Control group |
Primary outcome
Paronychia progress rate
Time frame: 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.
2 secondary outcomes
Time to paronychia progress
Time frame: Through study completion, an average of 10 days.
Time to paronychia relief
Time frame: Through study completion, an average of 10 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zanthoxylum nitidum tincture and tetracycline ointment in people with Paronychia, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanjuan Zhu, Dr (86 20 81887233 ext. 34830, zyjsophy@gzucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paronychia progress rate (time frame: Through study completion, an average of 10 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.