prospective randomised controlled study for superficial hemangioma: pulsed dye laser treatment versus wait-and-see-policy

prospective randomised controlled study for superficial hemangioma: pulsed dye laser treatment versus wait-and-see-policy - pulsed dye laser vs wait-and-see-policy for superficial hemangioma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33619

Enrollment

Registered

2009-02-10

Start date

2009-01-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

hemangiomen hemangioma strawberry mark

Interventions

Pulsed dye laser 595nm

spot diameter 7mm

30/10 epidermal cooling

fluence 7-15J/cm²

pulse duration 0,45-40ms

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients

Exclusion criteria

Exclusion criteria: subcutaneous/ compound hemangioma ulcerating hemangioma hemangioma associated with neurocutaneous syndromes hemangioma with very high risk of visual/ heardamage/ airway obstruction

Design outcomes

Primary

Measure	Time frame
Clearance : Complete remission or minimal residual signs (teleangiectasia, faint redness, minimal atrophic scarring, minimal pigment changes)	—

Secondary

Measure	Time frame
- redness - Stop growth - Tumor involution/ regression - Proliferation - Adverse outcome/ complication (required other treatment, ulceration, bleeding, infection, dyspigmentation, scars) - Residual signs - Parents quality of life - Cosmetic outcome - Cost benefit	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)