Topical Simvastatin for Treating Infantile Hemangioma (TSTIH)

Joyce Teng

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Hemangioma Skin

Treatments

Drug: 5% simvastatin ointment

Study type

Interventional

Funder types

Other

Identifiers

NCT06273111

73840

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

3 months to 5 years old

Volunteers

No Healthy Volunteers

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.