drugset / Trial / NCT06140186

Efficacy and Safety of Timolol for TKI Induced Paronychia

NCT06140186

Phase 3 Unknown 40 enrolled Queen Mary Hospital, Hong Kong
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-04-01
Primary completion
2023-12-31
Completion
2024-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Timolol Other / unclassified 0.5 % Topical
Comparator betamethasone valerate Small molecule 0.1 % Topical

Indications