RecruitingPhase 3NCT06643416

Efficacy and Safety of Add-on Timolol for EGFR-TKI and ALK-TKI Induced Paronychia

Efficacy and Safety of Add-on Topical Timolol in the Management of Epidermal Growth Factor and Anaplastic Lymphoma Kinase Receptor Tyrosine Kinase Inhibitor-induced Paronychia: a Prospective Randomized Open-labelled Trial

Sponsor

Queen Mary Hospital, Hong Kong

Enrollment

40 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

Paronychia EGFR-TKI ALK-TKI

Summary

To assess the clinical efficacy of add-on topical timolol 0.5% eye drops to betamethasone valerate 0.1% for the treatment of EGFR-TKI and ALK-TKI induced paronychia.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether topical timolol eye drops applied to the affected nails can treat paronychia (painful nail infections and inflammation) caused by certain targeted lung cancer drugs (EGFR-TKI and ALK-TKI therapies). **You may be eligible if...** - You are 18 years or older - You are being treated with an EGFR or ALK inhibitor for advanced non-small cell lung cancer (medications such as osimertinib, gefitinib, alectinib, or similar drugs) - You have developed paronychia (nail inflammation) as a side effect of this treatment **You may NOT be eligible if...** - You are under 18 years old - You are allergic to or have a contraindication to topical timolol - You are pregnant or breastfeeding - You have not consented to participate - You do not have advanced non-small cell lung cancer Talk to your doctor to see if this trial is right for you.

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Interventions

DRUGTimolol 0.5% eye drops and betamethasone valerate 0.1% cream

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. 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.

DRUGBetamethasone valerate 0.1% cream

The management according to routine clinical practice, including prescription of betamethasone valerate 0.1% cream 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.

Locations(1)

Queen Mary Hospital

Hong Kong, Hong Kong

View Full Details on ClinicalTrials.gov

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NCT06643416

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