Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT02913612
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
84 Days
Study:
NCT02913612
Study Brief:
Protocol Section:
NCT02913612