Phase 3
N=377
Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma
Hemangioma
Bottom Line
View on ClinicalTrials.gov: NCT02342275 ↗Enrolled (actual)
377
Serious AEs
2.1%
Results posted
Jun 2022
Primary outcome: Primary: The Primary Outcome Measure Was Any Response at 6 Months — 178; 173 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Propranolol (Drug); Atenolol (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- West China Hospital
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure Was Any Response at 6 Months |
178; 173 | <0.05 sig |
| SECONDARY Hemangioma Activity Score (HAS) |
4.61; 4.54; 3.31; 3.47; 2.42; 2.33 | — |
| SECONDARY Successful Initial Response |
171; 163 | — |
| SECONDARY Complete Ulceration Healing Time |
4.94; 4.82 | — |
| SECONDARY Rebound Rate |
19; 12 | — |
| SECONDARY Number of Participants With Complete/Nearly Complete Response (96 Week) |
156; 149 | — |
Summary
The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.
Eligibility Criteria
Inclusion Criteria
- Patients younger than 24 weeks.
- Presenting a hemangioma with the following characteristics:
- Subcutaneous and/or cutaneous
- Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.
- Consent of both parents (or the person having parental authority in families)
Exclusion Criteria
- Infant presenting contraindications for the administration of propranolol or atenolol.
- Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments.
- Patients with an inability to participate or to follow the study treatment and assessment plan.
Data sourced from ClinicalTrials.gov (NCT02342275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.