- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165082
The Efficacy of Topical Timolol Combined With Cryotherapy in EGFR Inhibitors-induced Paronychia - a Double-blinded, Intrapatient Left-to-right Controlled Study
The Efficacy of Topical Timolol Combined With Cryotherapy in EGFR Inhibitor-induced Paronychia - a Double-blinded, Intrapatient Left-to-right Controlled Study
Background: EGFR inhibitors (EGFRi) have been used to treat a wide variety of cancers nowadays. One of the major side effects of EGFRi is paronychia, which was not fatal but may caused huge negative impact on patient's daily activities. Current guidelines regarding EGFRi-induced paronychia suggested treatment with cryotherapy, topical corticosteroid or surgical intervention for Common Terminology Criteria for Adverse Events (CTCAE) grade 2 to grade 3 lesions. Recent studies showed that topical beta-blockers may be effective treatment for EGFRi- induced paronychia. However, the evidence was limited to case series and there was no randomized trials evaluating the efficacy.
Goal: To evaluate whether topical timolol combined with cryotherapy was more effective than cryotherapy alone in treating EGFR inhibitors-induced paronychia.
Method: In this single center, randomized, double-blinded, left-to-right comparison study, we plan to enroll 35 patients with EGFR inhibitors-induced paronychia. Patients eligible to enter this study should be over the age of 20 having at least one finger or toe involved with CTCAE grade 2~3 paronychia on each of their hands or feet. The paronychia should have no indication for surgical treatment. After enrollment, one physician will randomize the hands or feet to either timolol-plus-cryotherapy group or cryotherapy-alone group using a computer-generated random allocation scheme. The side allocated to the timolol-plus-cryotherapy group will receive topical timolol solution twice daily (since the beginning of the allocation and continue for 8 weeks) and topical cryotherapy with liquid nitrogen every other week (at the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial). The other side allocated to cryotherapy-alone group will receive placebo (normal saline) twice daily (since the beginning of the allocation and continue for 8 weeks) and topical cryotherapy with liquid nitrogen every other week (at the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial). In the treatment phase, patients may receive additional local or systemic antibiotics according to the dermatologist's clinical judgement, but they can not receive topical silver nitrate, trichloroacetic acid or corticosteroid ointment. Patients are evaluated at baseline, at 2, 4, 6 and 8 weeks after the initiation of treatment. Efficacy endpoints include CTCAE grade, scoring system for paronychia related to oncologic treatments (SPOT) and physician global assessment, which are evaluated by a blinded investigator based on digital photos, and pain VAS score and patient global assessment, which are evaluated by questionnaire to the patients.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu-Chen Huang, MD
- Phone Number: 2980 886-2-29307930
- Email: dhist2002@yahoo.com.tw
Study Contact Backup
- Name: Ya-Wen Hsiao, MD
- Phone Number: 2980 886-2-29307930
- Email: rosehsiao820907@gmail.com
Study Locations
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-
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Taipei, Taiwan
- Taipei Municipal Wan-Fang Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- EGFR inhibitors-induced paronychia
- Older than 20 years
- Having at least one finger or toe involved with CTCAE grade 2~3 paronychia on each of their hands or feet
Exclusion Criteria:
- Indication for surgical treatment
- Medical history of asthma, severe COPD, sinus bradycardia, SA block, 2nd to 3rd degree AV conduction delay, heart failure, cariogenic shock or allergy to timolol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Timolol plus cryotherapy
Apply topical timolol solution twice daily (since the beginning of the allocation and continue for 8 weeks) and cryotherapy with liquid nitrogen once every other week (on the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial).
|
Apply on affected finger or toes twice daily for 8 weeks
Other Names:
Conducted on affected finger or toes every other week for four sessions.
|
Placebo Comparator: Placebo plus cryotherapy
Apply placebo (normal saline) twice daily (since the beginning of the allocation and continue for 8 weeks) and cryotherapy with liquid nitrogen once every other week (on the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial).
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Conducted on affected finger or toes every other week for four sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scoring system for paronychia related to oncologic treatments (SPOT)
Time Frame: Evaluated at baseline
|
The SPOT evaluates severity of each hand or foot 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.
In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot.
The highest score of each parameter could originate from different fingers (or toes).
The total score of each hand (or foot) ranges from 0 to 12.
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Evaluated at baseline
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Scoring system for paronychia related to oncologic treatments (SPOT)
Time Frame: Evaluated at week 2 after the initiation of intervention
|
The SPOT evaluates severity of each hand or foot 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.
In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot.
The highest score of each parameter could originate from different fingers (or toes).
The total score of each hand (or foot) ranges from 0 to 12.
|
Evaluated at week 2 after the initiation of intervention
|
Scoring system for paronychia related to oncologic treatments (SPOT)
Time Frame: Evaluated at week 4 after the initiation of intervention
|
The SPOT evaluates severity of each hand or foot 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.
In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot.
The highest score of each parameter could originate from different fingers (or toes).
The total score of each hand (or foot) ranges from 0 to 12.
|
Evaluated at week 4 after the initiation of intervention
|
Scoring system for paronychia related to oncologic treatments (SPOT)
Time Frame: Evaluated at week 6 after the initiation of intervention
|
The SPOT evaluates severity of each hand or foot 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.
In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot.
The highest score of each parameter could originate from different fingers (or toes).
The total score of each hand (or foot) ranges from 0 to 12.
|
Evaluated at week 6 after the initiation of intervention
|
Scoring system for paronychia related to oncologic treatments (SPOT)
Time Frame: Evaluated at week 8 after the initiation of intervention
|
The SPOT evaluates severity of each hand or foot 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.
In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot.
The highest score of each parameter could originate from different fingers (or toes).
The total score of each hand (or foot) ranges from 0 to 12.
|
Evaluated at week 8 after the initiation of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain visual analogue scale
Time Frame: Evaluated at baseline, week 2, 4, 6 and 8 after the initiation of intervention
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Patients rate their severity of pain on a scale of 0 to 10, with 0 for no pain, 5 for moderate pain, and 10 for the worst pain ever experienced.
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Evaluated at baseline, week 2, 4, 6 and 8 after the initiation of intervention
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Physician global assessment
Time Frame: Evaluated at week 2, 4, 6 and 8 after the initiation of intervention
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The physician rates the improvement of lesions based on digital photographs on a scale of 0 to 6, representing: 0, total clearance (100% improvement);
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Evaluated at week 2, 4, 6 and 8 after the initiation of intervention
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Patient global assessment
Time Frame: Evaluated at week 2, 4, 6 and 8 after the initiation of intervention
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Patients rate their extent of improvement of lesions on a scale of 0 to 10, with 0 for no improvement, 5 for moderate improvement, and 10 for total clearance of lesions.
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Evaluated at week 2, 4, 6 and 8 after the initiation of intervention
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Collaborators and Investigators
Publications and helpful links
General Publications
- Chu CY, Chen KY, Wen-Cheng Chang J, Wei YF, Lee CH, Wang WM. Taiwanese Dermatological Association consensus for the prevention and management of epidermal growth factor receptor tyrosine kinase inhibitor-related skin toxicities. J Formos Med Assoc. 2017 Jun;116(6):413-423. doi: 10.1016/j.jfma.2017.03.001. Epub 2017 Mar 27.
- Yen CF, Hsu CK, Yang HS, Lee CN, Chi CC, Chung WH, Wang CL, Pang JS, Wang CW, Ko YS, Lu CW. Treatment of epidermal growth factor receptor inhibitor-induced severe paronychia with pyogenic granuloma-like lesions with topical betaxolol: an open-label observation study. Int J Dermatol. 2020 Mar;59(3):326-332. doi: 10.1111/ijd.14730. Epub 2019 Nov 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Skin Diseases, Infectious
- Nail Diseases
- Paronychia
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Pharmaceutical Solutions
- Timolol
- Ophthalmic Solutions
Other Study ID Numbers
- N202104033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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