Clinical trial NCT06140186: Efficacy and Safety of Timolol for TKI Induced Paronychia
Official title: Efficacy and Safety of add-on Topical Timolol in the Management of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor-induced Paronychia: A Prospective Randomized Open-labelled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Paronychia
Keywords: EGFR TKI
Paronychia
Timolol
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The difference in the proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding)
timeFrame: From baseline to month 3
Secondary outcomes:
measure: The proportion of patients achieved complete or partial response
timeFrame: From baseline to month 3
measure: Lack of response as well as proportion of patients with reduced severity of paronychia
timeFrame: From baseline to month 3
measure: Change in chronic paronychia severity index scale with treatment
timeFrame: From baseline to month 3
measure: The improvement of paronychia by 4 point scale
timeFrame: From baseline to month 3
measure: Change in severity of pain by Visual Analog Scale
timeFrame: From baseline to month 3
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Wang Chun Kwok, MBBS
role: PRINCIPAL_INVESTIGATOR
References: