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
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.