Efficacy and Safety of Add-on Timolol for EGFR-TKI and ALK-TKI Induced Paronychia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen Mary Hospital, Hong Kong
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or above, either males or females.
Received EGFR-TKI and ALK-TKI, namely gefitinib, erlotinib, afatinib, osimertinib, amivantamab, dacomitinib, mobocertinib, crizotinib, ceritinib, alectinib, brigatinib and lorlatinib for the treatment of non-small cell lung cancer.
Paronychia (fingernails, toenails, or both) as an adverse event from EGFR-TKI use
Written informed consent obtained from patient
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Timolol 0.5% eye drops and betamethasone valerate 0.1% cream
DrugTopical 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.
Betamethasone valerate 0.1% cream
DrugThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Timolol combination treatmentActive comparator 2 interventions
Group B: Routine ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding) on topical timolol 0.5% eye drops as compared to betamethasone valerate 0.1% lotion
The proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding) on topical timolol 0.5% eye drops as compared to betamethasone valerate 0.1% lotion
Time frame
From baseline to month 3Secondary outcomes
1
The proportion of patients achieved complete or partial response
Proportion of patients achieved complete or partial response (improvement in at least 1 of these 3 items).
Time frame
From baseline to month 32
Lack of response as well as proportion of patients with reduced severity of paronychia
Proportion of patients lack of response (improvement in less than 1 item)
Time frame
From baseline to month 33
Change in chronic paronychia severity index scale with treatment
Involvement of 1 nail fold = 1; involvement of 2 nail folds \[proximal or/and lateral\] = 2; bilateral lateral nail fold involvement and proximal nail fold involvement = 3), edema (absent = 0; mild = 1; moderate = 2; severe = 3), erythema (absent = 0; mild = 1; moderate = 2; severe = 3), nail plate changes (absent = 0; mild = 1; moderate = 2; severe = 3), and cuticle involvement (normal = 0; damaged = 1; absent = 2), producing a combined total score (between 0 \[min.\] and 14 \[max.\]
Time frame
From baseline to month 34
The improvement of paronychia by 4 point scale
1: 0 to \<30%, 2: 30 to \<50%, 3: 50 to 75%, 4: 75 to 100% improvement
Time frame
From baseline to month 3Sponsors and contacts
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Source ClinicalTrials.gov