Efficacy and Safety of Timolol for TKI Induced Paronychia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-03-31

Brief Summary

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This study would assess the clinical efficacy of add-on topical timolol 0.5% gel to betamethasone valerate 0.1% for the treatment of EGFR-TKI induced paronychia. Eligible patients, who develop paronychia (affecting fingernails, toenails or both), will be included in this study. They will be randomized in 1:1 ratio using computer-generated randomization list to receive either combination of topical timolol 0.5% gel and betamethasone valerate 0.1% lotion application twice daily or betamethasone valerate 0.1% lotion application twice daily. Patients in timolol combination treatment group will receive topical timolol 0.5% gel twice daily with occlusion (i.e. covered with adhesive badge) and betamethasone valerate 0.1% lotion twice daily with occlsuion for 1 month. Patients in routine arm would receive the management according to routine clinical practice, including prescription of betamethasone valerate 0.1% lotion twice daily for 1 month with occlusion. For patients who do not have paronychia completely resolved after 4 weeks, the treatment assigned will be continued for another 4 to 8 weeks , up to 12 weeks to see the effect.

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Detailed Description

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The aim of this study ist o assess the clinical efficacy of add-on topical timolol 0.5% gel to betamethasone valerate 0.1% for the treatment of EGFR-TKI induced paronychia.

Conditions

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Paronychia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

40 Adult patients aged 18 or above who received EGFR-TKI for the treatment of NSCLC, who develop paronychia (affecting fingernails, toenails or both), will be included in this study. Patients will be randomized in 1:1 ratio using computer-generated randomization list.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label trial, and no one will be masked

Study Groups

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Timolol combination treatment

Patients will received topical timolol 0.5% eye drops (liquid form) twice daily with occlusion (i.e. covered with adhesive badge) and betamethasone valerate 0.1% cream twice daily with occlsuion for 1 month

Group Type ACTIVE_COMPARATOR

Topical Timolol

Intervention Type DRUG

Topical timolol 0.5% eye drops (liquid form) twice daily with occlusion (i.e. covered with adhesive badge) and betamethasone valerate 0.1% cream twice daily with occlsuion for 1 month.

Routine arm

Patients in routine arm would receive the management according to routine clinical practice, including prescription of betamethasone valerate 0.1% cream twice daily for 1 month with occlusion.

Group Type ACTIVE_COMPARATOR

Betamethasone Valerate

Intervention Type DRUG

Betamethasone valerate 0.1% cream application twice daily

Interventions

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Topical Timolol

Topical timolol 0.5% eye drops (liquid form) twice daily with occlusion (i.e. covered with adhesive badge) and betamethasone valerate 0.1% cream twice daily with occlsuion for 1 month.

Intervention Type DRUG

Betamethasone Valerate

Betamethasone valerate 0.1% cream application twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 years or above, either males or females.
2. Received EGFR-TKI, namely gefitinib, erlotinib, afatinib, osimertinib, amivantamab, dacomitinib and mobocertinib.
3. Paronychia (fingernails, toenails, or both) as an adverse event from EGFR-TKI use.
4. Written informed consent obtained from patient.

Exclusion Criteria

1. Age below18.
2. Patients who are allergic to, or contraindicated to topical timolol use.
3. Pregnant women or nursing mother.
4. Non-consenting patients.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No