Topical Simvastatin for Treating Infantile Hemangioma

Conditions

• Hemangioma Skin

Eligibility Criteria

Sex

ALL

Age

3 Months - 6 Months

Healthy Volunteers

Not accepted

Interventions

• 5% simvastatin ointment — DRUG
  5% simvastatin ointment will be applied directly on IH lesion twice per day for 24 weeks

Study Details

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.

Key Dates

First listed

Feb 22, 2024

Start date

Nov 1, 2026

Status verified

Sep 2026

Primary completion

Mar 31, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 5% simvastatin ointment
  Participants will be applied 5% simvastatin ointment on IH lesion

Primary Outcome Measure

Evaluation of the safety and tolerability of the 5% simvastatin ointment over 48 weeks [ Time Frame: Baseline through week 48 ]

Central Contacts

• Joyce Teng, MD, PhD
  650-724-9627
  [email protected]
• Ramrada Lekwuttikarn, MD
  650-313-8207
  [email protected]

Locations (1)

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