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Purpose

The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5% doses.

Condition

Eligibility

Eligible Ages
Under 84 Days
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
0.25% Timolol Treatment 		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.
  • Drug: 0.25% Timolol Maleate Gel Forming Solution
    50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution
Experimental
0.5% Timolol Treatment 		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.
  • Drug: 0.5% Timolol Maleate Gel Forming Solution
    50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution
No Intervention
Non-Intervention Group 		Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group.

More Details

Status
Completed
Sponsor
Kanecia Obie Zimmerman

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.