Clinical trial · Interventional
Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)
Efficacy, Safety, and Pharmacokinetics of Timolol in Infants With Infantile Hemangioma (IH)
NCT02913612CI-TRIAL-00074939TIM01completedPhase 2Results 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 assess the safety and efficacy of Timolol 0.25% and 0.5% doses.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.25% Timolol Maleate Gel Forming Solution | Drug | — | UNRESOLVED |
| 0.5% Timolol Maleate Gel Forming Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 0.25% Timolol Treatment
- description
- Subjects assigned to this arm will be randomized to 0.25% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.25% timolol they will be changed to 0.5% timolol.
- interventionNames
- Drug: 0.25% Timolol Maleate Gel Forming Solution
- type
- EXPERIMENTAL
- label
- 0.5% Timolol Treatment
- description
- Subjects assigned to this arm will be randomized to 0.5% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.5% timolol the treating physician will decide to either continue 0.5% timolol or withdraw the subject and begin an alternative treatment.
- interventionNames
- Drug: 0.5% Timolol Maleate Gel Forming Solution
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 84 Days
Show eligibility criteria text
Inclusion Criteria 1. Documented informed consent from legal guardian 2. 0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort. 3. Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following): 1. Superficial lesion in the dermis 2. Thin \<2 mm in thickness 3. Small \>=5 cm at its longest dimension and \<=10cm2 4. Involves skin or keratinized mucosa Exclusion Criteria 1. History of previous treatment with any pharmacologic or laser therapy for IH 2. Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot (TOF), hypertension, reactive airways disease) 3. IH that requires systemic therapy (defined by dynamic complication scale \>3) 4. IH of the non-keratinized mucosa 5. Infants with more than one hemangioma that requires therapy 6. Hemodynamically significant cardiovascular disease, as determined by the investigator 7. Known allergy to beta blockers or vehicle 8. Heart rate \<100 beats per minute at screening visit 9. Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block 10. History of Reactive Airways Disease (RAD) 11. Any condition which would make the participant, in the opinion of the investigator unsuitable for the study.
References
Publications (1)
- BACKGROUNDDrolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee (See Acknowledgments for a listing of committee members.). Systemic timolol exposure following topical application to infantile hemangiomas. J Am Acad Dermatol. 2020 Mar;82(3):733-736. doi: 10.1016/j.jaad.2019.02.029. Epub 2019 Feb 18. No abstract available. PMID 30790601