Clinical trial · Interventional
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)
The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas
NCT01408056CI-TRIAL-00013493TOUCHwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty with recruitment
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infantile Hemangiomas | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mupirocin 2% Ointment | Drug | — | UNRESOLVED |
| Timolol 0.5% Gel Forming Solution (GFS) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Timolol 0.5% Gel Forming Solution (GFS)
- description
- Half of enrolled subjects will receive topical Timolol
- interventionNames
- Drug: Timolol 0.5% Gel Forming Solution (GFS)
- type
- ACTIVE_COMPARATOR
- label
- Mupirocin 2% ointment
- description
- Half of enrolled subjects will receive Mupirocin
- interventionNames
- Drug: Mupirocin 2% Ointment
Primary outcomes (1)
- measure
- Time to Wound Re-epithelization
- timeFrame
- At 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 8 Months
Show eligibility criteria text
Inclusion Criteria: * Infants weighing between 4-12kg * Infants with corrected gestational age 44 weeks - 8 months of age * Infant with an ulcerated hemangioma * Informed consent Exclusion Criteria: * Ulceration larger than 16cm2 * Ulcerated hemangioma with active bleeding or infection at time of enrollment * Disease threatening hemangioma meeting criteria for oral propranolol * Previous treatment with topical/oral corticosteroid or propranolol * Medical history of congenital heart disease with decreased cardiac output, stroke/cerebral vasculopathy, active reactive airway disease or metabolic disorder * History of an allergic reaction to Mupirocin or Timolol * Currently taking medication that would interact with beta-blockers
References
Publications (5)
- BACKGROUNDPope E, Chakkittakandiyil A. Topical timolol gel for infantile hemangiomas: a pilot study. Arch Dermatol. 2010 May;146(5):564-5. doi: 10.1001/archdermatol.2010.67. No abstract available. PMID 20479314
- BACKGROUNDSivamani RK, Pullar CE, Manabat-Hidalgo CG, Rocke DM, Carlsen RC, Greenhalgh DG, Isseroff RR. Stress-mediated increases in systemic and local epinephrine impair skin wound healing: potential new indication for beta blockers. PLoS Med. 2009 Jan 13;6(1):e12. doi: 10.1371/journal.pmed.1000012. PMID 19143471
- BACKGROUNDSans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10. PMID 19706583
- BACKGROUNDKhunger N, Pahwa M. Dramatic response to topical timolol lotion of a large hemifacial infantile haemangioma associated with PHACE syndrome. Br J Dermatol. 2011 Apr;164(4):886-8. doi: 10.1111/j.1365-2133.2010.10177.x. No abstract available. PMID 21158749
- BACKGROUNDChamlin SL, Haggstrom AN, Drolet BA, Baselga E, Frieden IJ, Garzon MC, Horii KA, Lucky AW, Metry DW, Newell B, Nopper AJ, Mancini AJ. Multicenter prospective study of ulcerated hemangiomas. J Pediatr. 2007 Dec;151(6):684-9, 689.e1. doi: 10.1016/j.jpeds.2007.04.055. Epub 2007 Aug 24. PMID 18035154