Clinical trial · Interventional
Timolol for the Prevention of Proliferation of Infantile Hemangioma (TiPPIH Trial)
Phase 1 Study of Topical Beta Blocker to Prevent the Proliferative Stage of Infantile Hemangioma
NCT01434849CI-TRIAL-00024805TiPPIHterminatedPhase 1ClinicalTrials.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 enrolled patients to complete trial.
Summary
Brief summary (as posted)
The purpose of this trial is to see if a topical beta blocker is effective in preventing the proliferation of infantile hemangioma.
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 |
|---|---|---|---|
| Infantile Hemangioma | Infantile Hemangioma | ONTOLOGY_EXACT | 0.98 |
| Very Low Birth Weight Infants | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control (placebo) group | Drug | — | UNRESOLVED |
| topical 0.5% Timolol maleate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Timolol
- description
- Application of 1-2 drops of Timolol maleate 0.5% ophthalmic aqueous solution to hemangioma twice daily.
- interventionNames
- Drug: topical 0.5% Timolol maleate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Application of 1-2 drops of placebo gel twice daily to hemangioma.
- interventionNames
- Drug: Control (placebo) group
Primary outcomes (1)
- measure
- Proportion of subjects in treatment group compared to placebo group with at least 50% improvement in the extent of hemangioma as compared to each other with respect to changes from baseline photographs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: * Babies admitted to NICU or seen in follow clinic that have a diagnosis of hemangioma that is verified by Principal Investigator (PI) or Co-Principal Investigators. Exclusion Criteria: * Babies with PHACES (Posterior fossa, Hemangioma, Arterial lesions, Cardiac abnormalities, Eye abnormalities) syndrome * Babies with cardiac conditions that may predispose to heart block * Babies with persistent hypoglycemia * Babies on medications that may interact with beta blockers * Babies who are hemodynamically unstable and are requiring pressors to maintain blood pressure * Babies who are on systemic corticosteroid therapy
References
Publications (0)
Data not yet available
No reference posted for this study.