Paronychia
Conditions
Keywords
EGFR TKI, Paronychia, Timolol
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.
Interventions
Betamethasone valerate 0.1% cream application twice daily
DRUGTopical Timolol
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.
Sponsors
Queen Mary Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label trial, and no one will be masked
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in the proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding) | From baseline to month 3 | The primary outcome of this study is 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% cream. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieved complete or partial response | From baseline to month 3 | Proportion of patients achieved complete or partial response (improvement in at least 1 of these 3 items) |
| Lack of response as well as proportion of patients with reduced severity of paronychia | From baseline to month 3 | Proportion of patients lack of response (improvement in less than 1 item) |
| Change in chronic paronychia severity index scale with treatment | From baseline to month 3 | 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 \[max.\] |
| The improvement of paronychia by 4 point scale | From baseline to month 3 | 1: 0 to \<30% , 2: 30 to \<50% ,3: 50 to 75% ,4: 75 to 100 % improvement) |
| Change in severity of pain by Visual Analog Scale | From baseline to month 3 | VAS scores ≤3.4cm corresponded to mild pain-related interference with functioning, scores of 3.5-6.4 to moderate interference, and scores ≥6.5 to severe interference. |
Countries
Hong Kong
Contacts
Primary ContactWang Chun Kwok, MBBS
Outcome results
None listed