Research with human participants

Overview of medical research in the Netherlands

Prospective study in congenital giant melanocytic naevi after curettage and laser ablation with the Erbium YAG laser (left-right comparison)

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Last updated:

Proof that laser treatment will be better than the routine method using curettage. Besides it is claimed that laser treatment is less painfull.This will be assessed by photography, in which only black white (grey) evaluations are made. Colours are…

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Ethical review
Approved WMO
Status
Pending
Health condition type
Congenital and hereditary disorders NEC
Study type
Interventional

ID

NL-OMON31799

Source

ToetsingOnline

Brief title

Treatment of congenital giant melanocytic naevi: curettage vs laserablation

Condition

  • Congenital and hereditary disorders NEC
  • Pigmentation disorders
  • Skin and subcutaneous tissue therapeutic procedures

Synonym

birthmarks, congenital moles

Research involving

Human

Sponsors and support

Primary sponsor :
Erasmus MC, Universitair Medisch Centrum Rotterdam
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
congenital giant melanocytaire naevi, curettage, Erbium YAG laser, laserablation

Outcome measures

Primary outcome

Clinical and photographically observation.

Secondary outcome

Pain adjustment

Background summary

The current treatment, with curettage leads to not-completely satisfied
results. It is claimed that laser ablation leads to better results and besides
it would be less painful.

Study objective

Proof that laser treatment will be better than the routine method using
curettage. Besides it is claimed that laser treatment is less painfull.
This will be assessed by photography, in which only black white (grey)
evaluations are made. Colours are influenced by environmental factors.
Besides we will proof that laser treatment will have a less negative effect on
painscores and quality of life.
The design of the study (left - right) makes it difficult to evaluate, but we
think that it is possible to indicate a difference between left and right
(especially with respect to the painscore).

Study design

Left, right randomised.

Intervention

surgical treatment

Study burden and risks

Not more than routinely happens.

Public
Erasmus MC, Universitair Medisch Centrum Rotterdam

Erasmus MC, locatie Rochussenstraat, Burg. s'Jacobplein 51
3015 CA ROTTERDAM
NL
Scientific
Erasmus MC, Universitair Medisch Centrum Rotterdam

Erasmus MC, locatie Rochussenstraat, Burg. s'Jacobplein 51
3015 CA ROTTERDAM
NL

Listed location countries

Netherlands

Age

Children (2-11 years)

Inclusion criteria

Patients with congenital giant melanocytic naevus

Exclusion criteria

Nevi smaller than 20 cm,
Another systemic disease.

Design

Study type :
Interventional
Intervention model
:
Other
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
25
Type :
Anticipated

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL16729.078.07