Clinical trial · Observational
Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination
Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination: a Single Center, Open Cohort Study.
NCT03842631CI-TRIAL-00037156unknownClinicalTrials.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 assess the safety and efficacy of Timolol Maleate treatment for different depth of infantile hemangioma based on B-ultrasonography. Based on the depth of hemangioma, patients will be proactively allocated to two groups. And then, all patients in both groups will receive topical timolol treatment in the same protocol and dosage.
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 Hemangioma | Infantile Hemangioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Timolol Maleate 0.5% Oph Soln | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Superficial Group
- description
- Hemangioma depth evaluated by B-ultrasonoscope is lower than or equal to 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma.
- interventionNames
- Drug: Timolol Maleate 0.5% Oph Soln
- label
- Deep Group
- description
- Hemangioma depth evaluated by B-ultrasonoscope is more than 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma.
- interventionNames
- Drug: Timolol Maleate 0.5% Oph Soln
Primary outcomes (1)
- measure
- Depth of infantile hemangioma
- timeFrame
- through study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: * Infants of 0 to 6 months of age * Skin Infantile hemangiomas (IHs) in the proliferation stage without prior treatment * IHs with a surface area of less than 1% of body surface area * Skin type III/IV Exclusion Criteria: * Ulcerated IHs. * Unsuitable for topical Timolol treatment due to anatomical location of lesion, eg. periorbital and lip IHs. * Patients with severe systemic or congenital disease which may affect the patient's safety in this study
References
Publications (0)
Data not yet available
No reference posted for this study.