ParonychiaPhase 3NCT06140186
Efficacy and Safety of Timolol for TKI Induced Paronychia
A Phase 3 study testing Topical Timolol and Betamethasone Valerate in people with Paronychia, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paronychia
- What is being tested?
- Topical Timolol and Betamethasone Valerate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2023to 31 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age below18.
- Patients who are allergic to, or contraindicated to topical timolol use.
- Pregnant women or nursing mother.
- Non-consenting patients.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Wang Chun Kwok, MBBS, +852 2255 5336, herbert728@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Paronychia
- Being tested
- Topical Timolol, Betamethasone Valerate
- Keywords
- EGFR TKI, Paronychia, Timolol
- Medical subject headings
- Paronychia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical TimololDrug
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 ValerateDrug
Betamethasone valerate 0.1% cream application twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Betamethasone Valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to month 3
Secondary outcomes (5)
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)
Measured: From baseline to month 3
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)
Measured: From baseline to month 3
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.]
Measured: From baseline to month 3
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)
Measured: From baseline to month 3
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.
Measured: From baseline to month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParonychiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwok Wang Chun, Queen Mary Hospital, Hong Kong
- Investigators
- Wang Chun Kwok, MBBS, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140186
- Sponsor's protocol ID
- UW 23-157
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06140186
- Acronym / sponsor ID
- UW 23-157
- Conditions
- Paronychia
- Keywords
- EGFR TKI, Paronychia, Timolol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Timolol combination treatment | Active comparator | Drug: Topical TimololPatients 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 |
| Routine arm | Active comparator | Drug: Betamethasone ValeratePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Age below18.
- Patients who are allergic to, or contraindicated to topical timolol use.
- Pregnant women or nursing mother.
- Non-consenting patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical TimololTopical 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 | Timolol combination treatment |
| Betamethasone ValerateBetamethasone valerate 0.1% cream application twice daily | Drug | Routine arm |
Primary outcome
The difference in the proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding)
Time frame: 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.
5 secondary outcomes
The proportion of patients achieved complete or partial response
Time frame: From baseline to month 3
Lack of response as well as proportion of patients with reduced severity of paronychia
Time frame: From baseline to month 3
Change in chronic paronychia severity index scale with treatment
Time frame: From baseline to month 3
The improvement of paronychia by 4 point scale
Time frame: From baseline to month 3
Change in severity of pain by Visual Analog Scale
Time frame: From baseline to month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Paronychia
Active, not recruitingPhase 2
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 2
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
Acneiform Eruption Due to Chemical, Xerosis Cutis
Active, not recruitingPhase 3
Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial.
Chronic Paronychia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Chun Kwok, MBBS principal investigator
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical Timolol and Betamethasone Valerate in people with Paronychia, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Chun Kwok, MBBS (+852 2255 5336, herbert728@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding) (time frame: From baseline to month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.