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

Childhood haemangioma is the most common soft tissue tumour of infancy,
occurring in
10 % of children under the age of one year. Less than 10% is present at birth,
while 90% appear within the first 4 weeks of life. The hallmark of haemangiomas
is a rapid proliferative phase, and a slower involutional phase. There are
three kinds of hemangioma: superficial, compound and subcutaneous. They all
start out as a superficial hemangioma.

During the proliferative phase complications can arise, such as bleeding,
infection, functional impairment due to obstruction of vital structures and
disfigurement. Most hemangioma are located on the face. Haemangioma with
complications that need treatment are more likely to be located on the face.
The anual resulution rate of hemangioma is 10% per year. In the first year,
around 5% will undergo complete remission. Therefore, the standard policy in
the Netherlands is a wait-and-see-policy.

Regression results in a normal skin texture in most patients, but residual skin
changes like teleangiectasia, atrophy, sagging, fibro fatty tissue residuum and
scarring, will remain in up to 50% of the patients. The most important
prognostic factors for the permanent damage left by involutive haemangiomas are
size, involvement of subcutaneous structures, and associated complications.
Haemangioma, especially located in the face, often cause great psychosocial
morbidity, affecting both parent and child. Therefore, it is desirable to have
the haemagioma removed before the child enters school.

The quest for a therapy that eliminates haemangiomas before development of
complications and without systemic or cutaneous adverse effects, has been
difficult. Treatment with the Pulsed Dye laser (PDL) is the gold standard for
treating vascular lesions. It is well established as the most effective, safe
treatment for port-wine-stains in children. A PDL treatment is easy feasible in
children under the age of 1 year and has little side effects.

Our aim is to do a prospective, randomised controlled study to ascertain
whether PDL treatment for superficial hemangioma influences

- complete remission rate
- growth (involution/ groth stop, proliferation)
- cosmetic outcome
- complications/ adverse events

Furthermore we will look at parent quality of live and cost -benefit

Main objective:
Clearance: Complete remission/ minimal residual signs

Secondary objective:
1. Stop growth
2. Regression
3. Proliferation
4. Reduction of redness
5. Residual signs
6. Adverse outcome/ complication (required other treatment, ulceration,
bleeding,
infection, dyspigmentation, scars)
7. Parents quality of life
8. Cost of treatment

prospective randomised controlled intervention study

Standardised Photographs: each visit
Color measurement: begin and
endpoint
length + width + volume measurement each visit
Color duplex sonography: begin age
3months, 6 months, 9 months and endpoint


Questionnaire parents quality of life: before and
after last treatment
Cost of treatment: last
visit

Treatment frequency: 2-6 weeks interval
Treatment will be continued until complete remission; stop proliferation; if
further treatment does not give improvement of the hemangioma; when there are
complications requiering other treatments; when the result is optimal and
further treatment will increase the chance of side effects; when the child
gives a lot of resistence to the treatment ( usually after the age of 1 year)

Pulsed dye laser 595nm; spot diameter 7mm; 30/10 epidermal cooling; fluence
7-15J/cm²; pulse duration 0,45-40ms

Treatment frequency: 2-6 weeks interval
Follow up: every 2-6 weeks, up to 1 year. If complete remission is acomplished
before one year of age of the patient, follow up is the same as in the control
group.
Treatment duration: seconds - 1 min.
Physical discomfort: children will be treated while they are being fed by their
care takers.
Discomfort (painful shocks and epidermal cooling) will only take a few seconds.
General/ local anaesthesia: no
Standardised Photographs: every visit
Color measurement: begin and endpoint
Color duplex sonography: begin, age 3 months, 6 months, 9 months, endpoint

complication/ adverse outcome (0-4%): atrophic scarring, dyspigmentation,
ulceration, infection