Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kanecia Obie Zimmerman
With
The Emmes Company, LLC
National Institutes of Health (NIH)
Primary: Describe the efficacy of 0.25% and 0.5% topical timolol maleate Gel-forming solution (GFS) as assessed through Infantile Hemangioma (IH) changes in volume.
Secondary: Describe the safety of topical timolol maleate GFS for treatment of IH.
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
