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Trial record 19 of 150 for:    tetracycline

Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib

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ClinicalTrials.gov Identifier: NCT03908892
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Haibo Zhang, Guangzhou University of Traditional Chinese Medicine

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).

Condition or disease Intervention/treatment Phase
Paronychia Drug: zanthoxylum nitidum tincture Drug: tetracycline ointment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study on the Treatment of Paronychia Caused by Afatinib With Zanthoxylum Nitidum Tincture
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination group
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
Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.

Drug: tetracycline ointment
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to paronychia progress [ Time Frame: 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.

  2. Time to paronychia relief [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908892


Contacts
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Contact: Yanjuan Zhu, Dr 86 20 81887233 ext 34830 zyjsophy@gzucm.edu.cn
Contact: Yihong Liu, Dr 80 20 81887233 ext 34830 yihongl@gzucm.edu.cn

Locations
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China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine

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Responsible Party: Haibo Zhang, Professor, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03908892     History of Changes
Other Study ID Numbers: 2019KT1122
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haibo Zhang, Guangzhou University of Traditional Chinese Medicine:
Paronychia
Zanthoxylum nitidum tincture
Afatinib
Additional relevant MeSH terms:
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Tetracycline
Paronychia
Skin Diseases, Infectious
Infection
Nail Diseases
Skin Diseases
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors