An open randomized controlled study of topical timolol maleate gel for the treatment of infant hemangioma: Comparison of safety and efficacy between topical timolol maleate gel and dye laser

An open randomized controlled study of topical timolol maleate gel for the treatment of infant hemangioma: Comparison of safety and efficacy between topical timolol maleate gel and dye laser - A controlled study of topical timolol maleate gel for the treatment of infant hemangioma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014761

Enrollment

Registered

2014-10-31

Start date

2013-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant hemangioma

Interventions

Small amount of 0.5% timolol maleate gel is applied to tumor two times a day for 6 months. The current standard dye laser treatment for infant hemangioma in Japan (aggressive irradiation treatment onl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Superficial infant hemangioma of less than 40 mm in diameter that is located in limbs or truncus.

Exclusion criteria

Exclusion criteria: Patients who have asthma, cardiovascular malformation, diabetes, poor weight gain, medication (including adrenaline, beta-blocker, calcium antagonist agent, digitalis product, CYP2D6 inhibitor), other skin disease, many infant hemangioma, congenital hemangioma. Patients who are ruled unfit to this study.

Design outcomes

Primary

Measure	Time frame
Size and color of tumor. We evaluate the short-term efficacy and safety with Photo-finish every month.	—

Secondary

Measure	Time frame
Condition of the affected skin. We check skin complications of the external medication every month.	—

Countries

Japan

Contacts

Public ContactNaoaki Rikihisa

Chiba University Hospital Dept. of plastic reconstructive, and aesthetic surgery

rikihisa@faculty.chiba-u.jp043-226-2316

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026