Clinical trial · Interventional
Efficacy and Safety of Add-on Timolol for EGFR-TKI and ALK-TKI Induced Paronychia
Efficacy and Safety of Add-on Topical Timolol in the Management of Epidermal Growth Factor and Anaplastic Lymphoma Kinase Receptor Tyrosine Kinase Inhibitor-induced Paronychia: a Prospective Randomized Open-labelled Trial
NCT06643416CI-TRIAL-00081721recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK-TKI | — | UNRESOLVED | — |
| EGFR-TKI | — | UNRESOLVED | — |
| Paronychia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Betamethasone valerate 0.1% cream | Drug | — | UNRESOLVED |
| Timolol 0.5% eye drops and betamethasone valerate 0.1% cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Timolol combination treatment
- description
- 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.
- interventionNames
- Drug: Timolol 0.5% eye drops and betamethasone valerate 0.1% cream
- Drug: Betamethasone valerate 0.1% cream
- type
- OTHER
- label
- Routine Arm
- description
- 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.
- interventionNames
- Drug: Betamethasone valerate 0.1% cream
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Aged 18 years or above, either males or females. 2. 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. 3. Paronychia (fingernails, toenails, or both) as an adverse event from EGFR-TKI use 4. Written informed consent obtained from patient 5. Subjects are diagnosed with advanced non-small cell lung cancer Exclusion criteria 1. 1\. Age below18 2. 2\. Patients who are allergic to, or contraindicated to topical timolol use 3. 3\. Pregnant women or nursing mother 4. 4\. Non-consenting patients 5. 5\. Subjects are not diagnosed with advanced non-small cell lung cancer
References
Publications (17)
- BACKGROUNDAtis G, Goktay F, Altan Ferhatoglu Z, Kaynak E, Sevim Kecici A, Yasar S, Aytekin S. A Proposal for a New Severity Index for the Evaluation of Chronic Paronychia. Skin Appendage Disord. 2018 Nov;5(1):32-37. doi: 10.1159/000489024. Epub 2018 May 30. PMID 30643778
- BACKGROUNDMartinez-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. PMID 31705590
- BACKGROUNDSibaud V, Casassa E, D'Andrea M. Are topical beta-blockers really effective "in real life" for targeted therapy-induced paronychia. Support Care Cancer. 2019 Jul;27(7):2341-2343. doi: 10.1007/s00520-019-04690-8. Epub 2019 Mar 7. PMID 30847700
- BACKGROUNDWalters S, Maringe C, Coleman MP, Peake MD, Butler J, Young N, Bergstrom S, Hanna L, Jakobsen E, Kolbeck K, Sundstrom S, Engholm G, Gavin A, Gjerstorff ML, Hatcher J, Johannesen TB, Linklater KM, McGahan CE, Steward J, Tracey E, Turner D, Richards MA, Rachet B; ICBP Module 1 Working Group. Lung cancer survival and stage at diagnosis in Australia, Canada, Denmark, Norway, Sweden and the UK: a population-based study, 2004-2007. Thorax. 2013 Jun;68(6):551-64. doi: 10.1136/thoraxjnl-2012-202297. Epub 2013 Feb 11. PMID 23399908
- BACKGROUNDPuttgen K, Lucky A, Adams D, Pope E, McCuaig C, Powell J, Feigenbaum D, Savva Y, Baselga E, Holland K, Drolet B, Siegel D, Morel KD, Garzon MC, Mathes E, Lauren C, Nopper A, Horii K, Newell B, Song W, Frieden I; Hemangioma Investigator Group. Topical Timolol Maleate Treatment of Infantile Hemangiomas. Pediatrics. 2016 Sep;138(3):e20160355. doi: 10.1542/peds.2016-0355. Epub 2016 Aug 15. PMID 27527799
- BACKGROUNDSequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.