CompletedPhase 2

Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)

United States105 participantsStarted 2017-05-05

Plain-language summary

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

Who can participate

Age range84 Days

SexALL

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Inclusion criteria

✓. Documented informed consent from legal guardian
✓. 0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.
✓. Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):
✓. Superficial lesion in the dermis
✓. Thin \<2 mm in thickness
✓. Small \>=5 cm at its longest dimension and \<=10cm2
✓. Involves skin or keratinized mucosa

Exclusion criteria

✕. History of previous treatment with any pharmacologic or laser therapy for IH
✕. 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)
✕. IH that requires systemic therapy (defined by dynamic complication scale \>3)
✕. IH of the non-keratinized mucosa
✕. Infants with more than one hemangioma that requires therapy
✕. Hemodynamically significant cardiovascular disease, as determined by the investigator
✕. Known allergy to beta blockers or vehicle
✕. Heart rate \<100 beats per minute at screening visit

What they're measuring

Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls

Timeframe: 180 days

Trial details

NCT IDNCT02913612

SponsorKanecia Obie Zimmerman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-20

Results submitted2022-10-20

View on ClinicalTrials.gov More Infantile Hemangioma trials