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Completed

NCT Number: NCT05165082

The Efficacy of Topical Timolol Combined With Cryotherapy in EGFR Inhibitors-induced Paronychia - a Double-blinded, Intrapatient Left-to-right Controlled Study

Background: EGFR inhibitors (EGFRi) have been used to treat a wide variety of cancers nowadays. One of the major side effects of EGFRi is paronychia, which was not fatal but may caused huge negative impact on patient's daily activities. Current guidelines regarding EGFRi-induced paronychia suggested treatment with cryotherapy, topical corticosteroid or surgical intervention for Common Terminology Criteria for Adverse Events (CTCAE) grade 2 to grade 3 lesions. Recent studies showed that topical beta-blockers may be effective treatment for EGFRi- induced paronychia. However, the evidence was limited to case series and there was no randomized trials evaluating the efficacy.

Goal: To evaluate whether topical timolol combined with cryotherapy was more effective than cryotherapy alone in treating EGFR inhibitors-induced paronychia.

Method: In this single center, randomized, double-blinded, left-to-right comparison study, we plan to enroll 35 patients with EGFR inhibitors-induced paronychia. Patients eligible to enter this study should be over the age of 20 having at least one finger or toe involved with CTCAE grade 2~3 paronychia on each of their hands or feet. The paronychia should have no indication for surgical treatment. After enrollment, one physician will randomize the hands or feet to either timolol-plus-cryotherapy group or cryotherapy-alone group using a computer-generated random allocation scheme. The side allocated to the timolol-plus-cryotherapy group will receive topical timolol solution twice daily (since the beginning of the allocation and continue for 8 weeks) and topical cryotherapy with liquid nitrogen every other week (at the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial). The other side allocated to cryotherapy-alone group will receive placebo (normal saline) twice daily (since the beginning of the allocation and continue for 8 weeks) and topical cryotherapy with liquid nitrogen every other week (at the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial). In the treatment phase, patients may receive additional local or systemic antibiotics according to the dermatologist's clinical judgement, but they can not receive topical silver nitrate, trichloroacetic acid or corticosteroid ointment. Patients are evaluated at baseline, at 2, 4, 6 and 8 weeks after the initiation of treatment. Efficacy endpoints include CTCAE grade, scoring system for paronychia related to oncologic treatments (SPOT) and physician global assessment, which are evaluated by a blinded investigator based on digital photos, and pain VAS score and patient global assessment, which are evaluated by questionnaire to the patients.

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Key information

Conditions

Paronychia Epidermal Growth Factor Receptor Inhibitor Infections Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Municipal Wan-Fang Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • EGFR inhibitors-induced paronychia
  • Older than 20 years
  • Having at least one finger or toe involved with CTCAE grade 2~3 paronychia on each of their hands or feet

Exclusion criteria

  • Indication for surgical treatment
  • Medical history of asthma, severe COPD, sinus bradycardia, SA block, 2nd to 3rd degree AV conduction delay, heart failure, cariogenic shock or allergy to timolol

Treatment and study plan

Timolol maleate 0.5% ophthalmic solution

Drug

Apply on affected finger or toes twice daily for 8 weeks

Other names: Timoptol

Cryotherapy with liquid nitrogen

Procedure

Conducted on affected finger or toes every other week for four sessions.

Primary outcomes

  1. Scoring system for paronychia related to oncologic treatments (SPOT)

    Time frame: Evaluated at baseline

    The SPOT evaluates severity of each hand or foot based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot. The highest score of each parameter could originate from different fingers (or toes). The total score of each hand (or foot) ranges from 0 to 12.

  2. Scoring system for paronychia related to oncologic treatments (SPOT)

    Time frame: Evaluated at week 2 after the initiation of intervention

    The SPOT evaluates severity of each hand or foot based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot. The highest score of each parameter could originate from different fingers (or toes). The total score of each hand (or foot) ranges from 0 to 12.

  3. Scoring system for paronychia related to oncologic treatments (SPOT)

    Time frame: Evaluated at week 4 after the initiation of intervention

    The SPOT evaluates severity of each hand or foot based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot. The highest score of each parameter could originate from different fingers (or toes). The total score of each hand (or foot) ranges from 0 to 12.

  4. Scoring system for paronychia related to oncologic treatments (SPOT)

    Time frame: Evaluated at week 6 after the initiation of intervention

    The SPOT evaluates severity of each hand or foot based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot. The highest score of each parameter could originate from different fingers (or toes). The total score of each hand (or foot) ranges from 0 to 12.

  5. Scoring system for paronychia related to oncologic treatments (SPOT)

    Time frame: Evaluated at week 8 after the initiation of intervention

    The SPOT evaluates severity of each hand or foot based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. In each parameter, the finger (or toe) with the highest score was selected to be representative of the hand (or foot), and the sum of the four parameters makes the total score of the hand or foot. The highest score of each parameter could originate from different fingers (or toes). The total score of each hand (or foot) ranges from 0 to 12.

Secondary outcomes

  1. Pain visual analogue scale

    Time frame: Evaluated at baseline, week 2, 4, 6 and 8 after the initiation of intervention

    Patients rate their severity of pain on a scale of 0 to 10, with 0 for no pain, 5 for moderate pain, and 10 for the worst pain ever experienced.

  2. Physician global assessment

    Time frame: Evaluated at week 2, 4, 6 and 8 after the initiation of intervention

    The physician rates the improvement of lesions based on digital photographs on a scale of 0 to 6, representing:

    0, total clearance (100% improvement);

    • almost total clearance (90% improvement);
    • distinct clearance (75% improvement);
    • moderate clearance (50% improvement);
    • mild clearance (25% improvement);
    • no change;
    • worse.

  3. Patient global assessment

    Time frame: Evaluated at week 2, 4, 6 and 8 after the initiation of intervention

    Patients rate their extent of improvement of lesions on a scale of 0 to 10, with 0 for no improvement, 5 for moderate improvement, and 10 for total clearance of lesions.

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

The Efficacy of Topical Timolol Combined With Cryotherapy in EGFR Inhibitor-induced Paronychia - a Double-blinded, Intrapatient Left-to-right Controlled Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2021
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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