Efficacy and Safety of Timolol for TKI Induced Paronychia

Queen Mary Hospital

Status and phase: Enrolling; Phase 3

Conditions: Paronychia

Treatments: Drug: Topical Timolol; Drug: Betamethasone Valerate

Study type: Interventional

Funder types: Other

Identifiers

NCT06140186

UW 23-157

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Timolol combination treatment

Active Comparator group

Description:

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

Treatment:

Drug: Topical Timolol

Routine arm

Active Comparator group

Description:

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.

Treatment:

Drug: Betamethasone Valerate