Efficacy and Safety of Add-on Timolol for EGFR-TKI and ALK-TKI Induced Paronychia

NCT06643416 | Recruiting Phase 3 DMC

• 1 other identifier: UW 24-573
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Paronychia; EGFR-TKI; ALK-TKI

Keywords

EGFR TKI; paronychia; timolol; ALK-TKI

Outcome Measures

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

  From baseline to month 3

Secondary Outcomes (5)

• The proportion of patients achieved complete or partial response

  From baseline to month 3

• Lack of response as well as proportion of patients with reduced severity of paronychia

  From baseline to month 3

• Change in chronic paronychia severity index scale with treatment

  From baseline to month 3

• The improvement of paronychia by 4 point scale

  From baseline to month 3

• Change in severity of pain by Visual Analog Scale

  From baseline to month 3

Study Arms (2)

Timolol combination treatment

ACTIVE COMPARATOR

Patients will received 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. 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.

Drug: Timolol 0.5% eye drops and betamethasone valerate 0.1% cream; Drug: Betamethasone valerate 0.1% cream

Routine Arm

OTHER

Patients in routine arm would receive the 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.

Drug: Betamethasone valerate 0.1% cream

Interventions

Timolol 0.5% eye drops and betamethasone valerate 0.1% cream DRUG

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. 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.

Timolol combination treatment

Betamethasone valerate 0.1% cream DRUG

The 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.

Routine Arm; Timolol combination treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects are diagnosed with advanced non-small cell lung cancer

You may not qualify if:

• \. Age below18
• \. Patients who are allergic to, or contraindicated to topical timolol use
• \. Pregnant women or nursing mother
• \. Non-consenting patients
• \. Subjects are not diagnosed with advanced non-small cell lung cancer

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (17)

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  PMID: 30643778 BACKGROUND

• Martinez-de-Espronceda I, Bernabeu-Wittel J, Azcona M, Monserrat MT. Recalcitrant trametinib-induced paronychia treated successfully with topical timolol in a pediatric patient. Dermatol Ther. 2020 Jan;33(1):e13164. doi: 10.1111/dth.13164. Epub 2019 Nov 15.

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MeSH Terms

Conditions

Paronychia

Interventions

Timolol; Ophthalmic Solutions; Betamethasone Valerate

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Wang Chun Kwok

CONTACT

+85222555336; kwokwch@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 40 Adult patients aged 18 or above who 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, who develop paronychia (affecting fingernails, toenails or both),as an adverse event from EGFR-TKI use will be included in this study. Patients will be randomized in 1:1 ratio using computer-generated randomization list to receive either combination of topical timolol 0.5% eye drops and betamethasone valerate 0.1% lotion application twice daily or betamethasone valerate 0.1% lotion application twice daily.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: October 9, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)