Behandeling van intertrigo met zinkoxide in ketoconazolcreme met of zonder toevoeging van hydrocortisonacetaat

Intertrigo is a skin disease especially seen in hospitals and other
care-centers. This disease starts in the large skin folds as the groin,
inframammary and in the axillae. There is no consensus for the treatment at
this moment but the main point is to dry the skin. Of all the topical
treatments, only the anti-myotics have an controled investigation.
In the Medical Center of Leeuwarden intertrigo is treatened with the
combination of zinc oxide in ketoconazol or zinc oxide and
hydrocortisone-acetaat in ketoconazole. Zinc oxide is to dry-in the skin,
ketoconazole for the dermatofyt or yeast and hydrocortisone-acetaat for the
redness and irritation of the skin.

Clinical trial to investigate a difference in effectiveness for the treatment
of intertrigo in wich the combination of zinc oxide 10% in ketoconazole will to
be compared with zinc oxide 10% and hydrocortisone-acetaat 1% in ketoconazole.

It is a dubble-bline, randomized, standardtherapy-controled phase III study,
with a duration of aproximately 6 months. There is an minimum of 48 inclusions
for the statistical calculations so there will be approximately 65
participants.

All patients will have both the combination with substitution with
hydrocortisone-acetaat as the cream combination without it.

There will be no extra burdening when a patient participate in our study
because the study is therapeuticaly. Physical there may be a burdening because
of the location of the intertrigo, wich are on the whole the intimate areas.
For the study it is necessary to have a good look at the intertrigo and trace
it onto foil. This has to be done twice.
A sample has to be taken once, but this is a part of the normal care for the
patients.
No invasive treatment is necessary in the interest of the study.