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.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduce in percentage of the area of the intertigo compared to the other side
that has not been treated with the hydrocortisone-acetaat.
Secondary outcome
Local complainments as pruritis, pain, redness and scaly. Also the results of
the cultured samples are evaluate whereby we will look at the percentage of
positive results and the reaction or the different treatments.
Background summary
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.
Study objective
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.
Study design
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.
Intervention
All patients will have both the combination with substitution with
hydrocortisone-acetaat as the cream combination without it.
Study burden and risks
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.
Henri Dunantweg 2
8934 AD Leeuwarden
Nederland
Henri Dunantweg 2
8934 AD Leeuwarden
Nederland
Listed location countries
Age
Inclusion criteria
- Two-sided intertrigo in the folds of the groin, axillairy or submammary
- The intertrigo may not been treated yet beside treatment with zincoxide.
- There has to be a control after 5-7 days.
Exclusion criteria
- Patients may not have a hypersensibility for one of the componements of the different creams
- Patients may not have a (skin)disease that might can influence the aspect or the threatment for this study neither have a contraindication to start the treatment.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2006-006234-18-NL |
| CCMO | NL15277.099.06 |