Clinical trial · Interventional
Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas
Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study
NCT01147601CI-TRIAL-00028490terminatedEarly Phase 1Results postedClinicalTrials.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)
The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.
Conditions
Conditions (2)
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 |
| Infant | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control (placebo) group | Drug | — | UNRESOLVED |
| topical 0.5% Timolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Topical 0.5% Timolol
- description
- Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
- interventionNames
- Drug: topical 0.5% Timolol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
- interventionNames
- Drug: Control (placebo) group
Primary outcomes (1)
- measure
- Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 8 Months
Show eligibility criteria text
Inclusion Criteria: Infants 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities. Exclusion Criteria: 1. Subjects with facial, genital, perianal, hand, finger, feet, or toe IH 2. Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES . 3. Subjects with IH measuring more than 3cm in size or ulcerated. 4. Children with a history of hypersensitivity to beta blockers. 5. Children with a personal history of asthma. 6. Children with known renal impairment. 7. Children with known cardiac conditions that may predispose to heart block 8. Personal history of hypoglycemia 9. Children on medications that may interact with beta blockers
References
Publications (0)
Data not yet available
No reference posted for this study.