This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH.

The primary objective:

To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks.

The secondary objective:

1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. 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.

Inclusion Criteria:

• Healthy children aged between 3 months and 5 years.

• Newly diagnosed superficial IH or experiencing rebound growth with a superficial component.

• Participants must possess at least one IH lesion with the longest diameter equal to or greater than 2 cm, located on any part of the body except the lips.

• Participants must not have received any of the following treatments for their IH:

  • Topical medical therapy within the past 2 weeks.
  • Systemic medical therapy within the past 3 months.
  • Laser treatment within the past 6 weeks.

• Written informed consent from the parent(s)/guardian(s) of minor participants must be obtained before any study procedure is performed.

Exclusion Criteria:

• IH is primarily characterized as subcutaneous, and deep, with minimal cutaneous involvement for evaluation.
• IH with active ulceration.
• IH to be treated involving the lips mainly.
• Participants with concurrent skin conditions that may impede accurate clinical assessment of the IH.
• Participants with hereditary or metabolic disorders requiring systemic statin therapy.
• Participants who are allergic to statins, or other ingredients present in the topical medication.