Joyce Teng
This is a 48-week, open-label pilot study to evaluate the safety, including systemic exposure and skin tolerability, and preliminary efficacy of 5% simvastatin ointment in the treatment of 15 children with newly diagnosed superficial proliferating IH. The primary objective: To evaluate the safety, including systemic exposure and skin tolerability of topical treatment with 5% simvastatin ointment for superficial proliferating IH over 48 weeks. The secondary objective: 1.1 To evaluate the efficacy and durability of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks, followed by a 24-week post-treatment follow-up period. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS). 1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire. The exploratory objective: To explore whether clinical response and regrowth following topical 5% simvastatin treatment are associated with SOX18-mevalonate pathway-axis activation in infantile hemangioma tissue.
Inclusion Criteria: Participants may be included in the study only if they meet all of the following criteria: 1. Healthy children aged between 3-6 months without medical disorders that contradict topical statin treatment. 2. Infants with newly diagnosed superficial IH. \[3\] Participants must possess at least one IH lesion with the longest diameter equal to or greater than 1 cm but less than 1% BSA, located on any part of the body except the lips. \[4\] Written informed consent from the parent(s)/guardian(s) must be obtained before any study procedure is performed. \[5\] Parent(s)/guardia…
5% simvastatin ointment will be applied directly on IH lesion twice per day for 24 weeks
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