Clinical trial · Interventional
Topical Timolol for Infantile Hemangioma in Early Proliferative Phase
Efficacy and Safety of Topical Timolol Maleate 0.5% Solution for Superficial Infantile Hemangioma in Early Proliferative Phase. A Randomized Clinical Trial
- 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)
Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.
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 |
|---|---|---|---|
| Hemangioma | Hemangioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Timolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Timolol
- description
- Timolol maleate 0.5% topical solution; 50% of the patients treated (randomized)
- interventionNames
- Drug: Timolol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Saline topical solution; 50% of the patients treated (randomized)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Complete or almost complete resolution of the lesions
- timeFrame
- 24 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Days
- Maximum age
- 60 Days
Show eligibility criteria text
Inclusion Criteria: * Written informed consent for study participation and the use of the patient's photographs from the patient's parent(s) or guardian(s), * The patient is between 10 and 60 days of age at the time of enrollment, * The patient should have: * at least one focal or segmental hemangioma, mixed or superficial, present anywhere on the body of at least 0.3 cm of minimum diameter and not greater of 5 cm. * abortive or minimal growth hemangioma * Infantile hemangioma precursors Exclusion Criteria: * Patients \> 60 days of age * Complicated hemangiomas (life-threatening, function-threatening, or ulcerated) * Children who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers, PDL laser. * Patients with PHACES, LUMBAR, SACRAL or PELVIS syndrome. * Internal involvement hemangiomas (liver, GI tract, larynx) * Children with a personal history of asthma or cardiac conditions that may predispose to heart block. * Children with congenital birth defects * Children with Cancer (leukemia, sarcoma, neuroblastoma, retinoblastoma) * Children with a history of hypersensitivity to beta blockers or excipients.
References
Publications (0)
Data not yet available