Topical Simvastatin for Treating Infantile Hemangioma

NCT ID: NCT06273111

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Hemangioma Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5% simvastatin ointment

Participants will be applied 5% simvastatin ointment on IH lesion

Group Type: EXPERIMENTAL

5% simvastatin ointment

Intervention Type: DRUG

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

Interventions

5% simvastatin ointment

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Joyce Teng

OTHER

Sponsor Role: lead

Responsible Party

Joyce Teng

Professor of Dermatology and Pediatric

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joyce Teng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Central Contacts

Joyce Teng, MD, PhD

Role: CONTACT

jteng3@stanford.edu

650-724-9627

Ramrada Lekwuttikarn, MD

Role: CONTACT

ramrada1@stanford.edu

650-313-8207

Facility Contacts

Ramrada Lekwuttikarn, MD

Role: primary

ramrada1@stanford.edu

650-313-8207

Thomas Buschbacher

Role: backup

tbusch@stanford.edu

352-278-7603

Other Identifiers

73840

Identifier Type: -

Identifier Source: org_study_id