Efficacy and Safety of Timolol for TKI Induced Paronychia

NCT06140186 | Unknown Phase 3 DMC

• 1 other identifier: UW 23-157
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Paronychia

Keywords

EGFR TKI; Paronychia; Timolol

Outcome Measures

Primary Outcomes (1)

• 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 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

Drug: Topical Timolol

Routine arm

ACTIVE COMPARATOR

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.

Drug: Betamethasone Valerate

Interventions

Topical Timolol 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.

Timolol combination treatment

Betamethasone Valerate DRUG

Betamethasone valerate 0.1% cream application twice daily

Routine arm

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, namely gefitinib, erlotinib, afatinib, osimertinib, amivantamab, dacomitinib and mobocertinib.
• Paronychia (fingernails, toenails, or both) as an adverse event from EGFR-TKI use.
• Written informed consent obtained from patient.

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.

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Paronychia

Interventions

Timolol; 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; Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Wang Chun Kwok, MBBS

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Chun Kwok, MBBS

CONTACT

+852 2255 5336; herbert728@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial, and no one will be masked
• 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 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.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)