Efficacy and Safety of Timolol for TKI Induced Paronychia

Paronychia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140186
• Other study ID #: UW 23-157
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2023
• Source: Queen Mary Hospital, Hong Kong
• Contact: Wang Chun Kwok, MBBS
• Phone: +852 2255 5336
• Email: herbert728[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Paronychia

Intervention

Drug:
• Topical 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.
• Betamethasone Valerate
Betamethasone valerate 0.1% cream application twice daily

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding)	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.	From baseline to month 3
Secondary	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)	From baseline to month 3
Secondary	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)	From baseline to month 3
Secondary	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.]	From baseline to month 3
Secondary	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)	From baseline to month 3
Secondary	Change in severity of pain by Visual Analog Scale	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.	From baseline to month 3