ParonychiaNCT06411093
Efficacy and Safety of Kinesiology Tape Wrapping for Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors
A study testing Kinesiology tape wrapping and Conventional treatment including silver nitrate cauterization in people with Paronychia and Epidermal Growth Factor Receptor Inhibitor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Epidermal growth factor receptor inhibitors(EGFRIs) have been applied in several common malignancies including advanced non-small cell lung cancer. Paronychia is one of the most common cutaneous side effects, characterized by inflamed granulation tissue around the nails leading to pain and reduced quality of life. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Paronychia, Epidermal Growth Factor Receptor Inhibitor
- What is being tested?
- Kinesiology tape wrapping and Conventional treatment including silver nitrate cauterization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2023to 31 Dec 2023
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EGFR inhibitors-induced paronychia
- Having at least one big toe involved with CTCAE(Common Terminology Criteria for Adverse Events) grade 2-3 paronychia
Who cannot join
- Younger than 20 years
- severe ingrown nails
- concomitant cutaneous infection
- severe nail destruction
- chronic paronychia with severe periungual fibrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Open-labelled Trial to Evaluate the Efficacy and Safety of the Kinesiology Tape for the Treatment of Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors in Cancer Patients
Epidermal growth factor receptor inhibitors(EGFRIs) have been applied in several common malignancies including advanced non-small cell lung cancer. Paronychia is one of the most common cutaneous side effects, characterized by inflamed granulation tissue around the nails leading to pain and reduced quality of life. Despite available conventional therapies such as topical beta-blockers or chemical cauterization, some patients still do not respond well. Our previous pilot study suggested that adding Kinesiology tape wrapping to the conventional treatment may effectively improve pain and granulomas in patients with treatment-resistant EGFRI-related paronychia, with good safety. This study aims to evaluate the clinical efficacy and safety of using Kinesiology tape wrapping as an adjunct to conventional therapy for patients with EGFRI-related paronychia.
Read the detailed description
In this study, eligible patients with paronychia affecting their big toes will be included and randomized to receive a combination of Kinesiology tape wrapping and conventional treatment, or conventional treatment alone for 3 months. Patients are evaluated at baseline, at 1, 2, 4, 8, and 12 weeks after the initiation of the treatment. These evaluations will occur at the outpatient department or through phone contact and photos taken by patients if they cannot visit in person. Efficacy endpoints include pain numerical rating scale (NRS) and scoring system for paronychia related to oncologic treatments (SPOT). Besides, any side effects will be recorded at each visit.
- Being tested
- Kinesiology tape wrapping, Conventional treatment including silver nitrate cauterization
- Medical subject headings
- Paronychia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology tape wrappingCombination product
Also called "NITTO"Medical Adhesive Tape (Non-Sterile)
Place Kinesiology tape between the nail plate and the inflamed periungual granulation tissue in addition to conventional treatment for 3 months
Conventional treatment including silver nitrate cauterizationDrug
Conventional treatment including silver nitrate cauterization, with or without topical antiseptics, topical steroids, topical beta-blockers, short-term systemic antibiotics, systemic steroids for 3 months
| Study group | Role | What they receive |
|---|---|---|
| A combination of Kinesiology tape wrapping and conventional treatment | Experimental | Patients in the intervention arm will receive Kinesiology tape wrapping to separate the nail plate from the inflamed periungual tissue in addition to conventional treatment. This intervention will be applied at outpatient visits or during hospitalization. If the Kinesiology tape falls off, patients can either replace it themselves or leave it off until the next outpatient visit or unexpected hospitalization. Receives: Combination Product: Kinesiology tape wrapping; Drug: Conventional treatment including silver nitrate cauterization |
| Conventional treatment | Active comparator | Patients in this arm will receive management according to routine clinical practice, including chemical cauterization with silver nitrate, with or without topical antiseptics, topical steroids, topical beta-blockers, systemic steroids, and systemic antibiotics. The above treatment will be applied at outpatient visits or during hospitalization. Receives: Drug: Conventional treatment including silver nitrate cauterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the severity of pain by Numerical Rating Scale
Patients rate the severity of pain over the tender point of the affected big toe on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.
Measured: Evaluated at week 1, 2, 4, 6, 8 and 12 after the initiation of intervention
Change in the severity of paronychia by the scoring system for paronychia related to oncologic treatments (SPOT)
The SPOT evaluates the severity of the affected big toe based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. The total score ranges from 0 to 12.
Measured: Evaluated at week 2, 4, 6, 8 and 12 after the initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start2 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParonychiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting-Jung Hsu, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411093
- Sponsor's protocol ID
- 202001747A3
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsu TJ, Yeh HH, Liu KL. Kinesiology tapes wrapping for paronychia induced by epidermal growth factor receptor inhibitors: A pilot study. Dermatol Ther. 2022 Jun;35(6):e15463. doi: 10.1111/dth.15463. Epub 2022 Mar 29. No abstract available.
PubMed 35307912
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-labelled Trial to Evaluate the Efficacy and Safety of the Kinesiology Tape for the Treatment of Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors in Cancer Patients
- ClinicalTrials.gov ID
- NCT06411093
- Acronym / sponsor ID
- 202001747A3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 May 2024 (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.
Epidermal growth factor receptor inhibitors(EGFRIs) have been applied in several common malignancies including advanced non-small cell lung cancer. Paronychia is one of the most common cutaneous side effects, characterized by inflamed granulation tissue around the nails leading to pain and reduced quality of life. Despite available conventional therapies such as topical beta-blockers or chemical cauterization, some patients still do not respond well. Our previous pilot study suggested that adding Kinesiology tape wrapping to the conventional treatment may effectively improve pain and granulomas in patients with treatment-resistant EGFRI-related paronychia, with good safety. This study aims to evaluate the clinical efficacy and safety of using Kinesiology tape wrapping as an adjunct to conventional therapy for patients with EGFRI-related paronychia.
Detailed description
In this study, eligible patients with paronychia affecting their big toes will be included and randomized to receive a combination of Kinesiology tape wrapping and conventional treatment, or conventional treatment alone for 3 months. Patients are evaluated at baseline, at 1, 2, 4, 8, and 12 weeks after the initiation of the treatment. These evaluations will occur at the outpatient department or through phone contact and photos taken by patients if they cannot visit in person. Efficacy endpoints include pain numerical rating scale (NRS) and scoring system for paronychia related to oncologic treatments (SPOT). Besides, any side effects will be recorded at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A combination of Kinesiology tape wrapping and conventional treatment | Experimental | Combination Product: Kinesiology tape wrapping, Drug: Conventional treatment including silver nitrate cauterizationPatients in the intervention arm will receive Kinesiology tape wrapping to separate the nail plate from the inflamed periungual tissue in addition to conventional treatment. This intervention will be applied at outpatient visits or during hospitalization. If the Kinesiology tape falls off, patients can either replace it themselves or leave it off until the next outpatient visit or unexpected hospitalization. |
| Conventional treatment | Active comparator | Drug: Conventional treatment including silver nitrate cauterizationPatients in this arm will receive management according to routine clinical practice, including chemical cauterization with silver nitrate, with or without topical antiseptics, topical steroids, topical beta-blockers, systemic steroids, and systemic antibiotics. The above treatment will be applied at outpatient visits or during hospitalization. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- EGFR inhibitors-induced paronychia
- Having at least one big toe involved with CTCAE(Common Terminology Criteria for Adverse Events) grade 2-3 paronychia
Key exclusion criteria (5 listed)
- Younger than 20 years
- severe ingrown nails
- concomitant cutaneous infection
- severe nail destruction
- chronic paronychia with severe periungual fibrosis
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 |
|---|---|---|
| Kinesiology tape wrappingAlso: "NITTO"Medical Adhesive Tape (Non-Sterile)Place Kinesiology tape between the nail plate and the inflamed periungual granulation tissue in addition to conventional treatment for 3 months | Combination product | A combination of Kinesiology tape wrapping and conventional treatment |
| Conventional treatment including silver nitrate cauterizationConventional treatment including silver nitrate cauterization, with or without topical antiseptics, topical steroids, topical beta-blockers, short-term systemic antibiotics, systemic steroids for 3 months | Drug | A combination of Kinesiology tape wrapping and conventional treatment, Conventional treatment |
Primary outcome
Change in the severity of pain by Numerical Rating Scale
Time frame: Evaluated at week 1, 2, 4, 6, 8 and 12 after the initiation of intervention
Patients rate the severity of pain over the tender point of the affected big toe on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.
Change in the severity of paronychia by the scoring system for paronychia related to oncologic treatments (SPOT)
Time frame: Evaluated at week 2, 4, 6, 8 and 12 after the initiation of intervention
The SPOT evaluates the severity of the affected big toe based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. The total score ranges from 0 to 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 35307912Hsu TJ, Yeh HH, Liu KL. Kinesiology tapes wrapping for paronychia induced by epidermal growth factor receptor inhibitors: A pilot study. Dermatol Ther. 2022 Jun;35(6):e15463. doi: 10.1111/dth.15463. Epub 2022 Mar 29. No abstract available.
Related trials for Paronychia
Active, not recruitingPhase 2
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 2
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
Acneiform Eruption Due to Chemical, Xerosis Cutis
Active, not recruitingPhase 3
Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial.
Chronic Paronychia
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.
Ting-Jung Hsu, M.D. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiology tape wrapping and Conventional treatment including silver nitrate cauterization in people with Paronychia and Epidermal Growth Factor Receptor Inhibitor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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: finished, as of the sponsor's last update on 13 May 2024. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the severity of pain by Numerical Rating Scale (time frame: Evaluated at week 1, 2, 4, 6, 8 and 12 after the initiation of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06411093, which also lists 1 linked publication.
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 13 May 2024.