Clinical trial · Interventional
Topical Timolol Gel for the Treatment of Infantile Hemangiomas
NCT02145884CI-TRIAL-00025934completedPhase 2ClinicalTrials.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)
We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| timolol maleate 0.5% gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- timolol maleate 0.5% gel
- description
- timolol gel 1 to 2 drops twice a day to lesions for 4 months
- interventionNames
- Drug: timolol maleate 0.5% gel
Primary outcomes (2)
- measure
- Change in size of hemangioma
- timeFrame
- Baseline, week 2, 4, 8, 12, 16
- description
- At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm.
- measure
- Change in color of hemangioma
- timeFrame
- Baseline, week 2, 4, 8, 12, 16
- description
- At each visit, the color intensity (e.g., barely perceptible; pale pink or mottled pink/red; red with central pallor; dull red; bright red) of the IH is assessed on a 6 point scale.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Days
- Maximum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: * Written informed permission for study participation and the use of the patient's images are obtained from the patient's parent(s) or guardian(s), * The patient is between 7 days and 6 months of age at the time of enrollment, * and a proliferating HOI not requiring systemic therapy is present anywhere on the body, Multiple hemangiomas may be treated on same child, if the hemangioma meets this criteria. Exclusion Criteria: * patients who are not otherwise generally healthy; * at risk for imminent ulceration, life-threatening, function-threatening, or ulcerated; * patients who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers; * patients who have previously been treated for his/her HOI, including any surgical and/or medical procedures; * patients whose mothers have been breastfeeding the patient while also being treated with beta-blockers, systemic corticosteroids, vincristine or alpha-interferon; * patients who have previously experienced any anaphylactic reactions; patients with an unclear diagnosis of HOI; * patients participating in another clinical study or living in the same household as an infant already participating in this study; * patients born prematurely who have not yet reached his/her term equivalent age; and patients with parent(s) or guardian(s) who cannot be contacted by telephone in case of emergency.
References
Publications (0)
Data not yet available
No reference posted for this study.