Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
The development of the topical calcineurin inhibitor pimecrolimus resulted in a significant
improvement in the treatment of atopic dermatitis. In addition, an excellent amelioration of
pruritus could be regularly observed. Up to now, several itchy dermatoses such as chronic
irritative hand dermatitis, rosacea, graft-versus-host-disease, lichen sclerosus, prurigo
simplex, scrotal eczema, and inverse psoriasis were reported as single cases also to respond
to a pimecrolimus treatment.
In prurigo nodularis, pruritus is the main symptom and it is of immediate importance to find
an effective antipruritic therapy. Pruritus is regularly severe and therapy refractory to
topical steroids or systemic antihistamines. Capsaicin cream is one effective possibility to
reduce the itch in these diseases. However, it has to be applied 3 to 6 times daily, rubs off
on the clothing and induces burning in erosions. In addition, since no commercial preparation
is available, it has to be prescribed in several concentrations. The application of
pimecrolimus seems to be promising since it has to be applied twice daily only. Especially in
prurigo nodularis we expect a good response as we could demonstrate in single patients.
Furthermore it has been published recently that Tacrolimus, another calcineurin inhibitor has
been successfully used in the treatment of six patients with prurigo nodularis.
This study is designed to compare the efficacy and safety of pimecrolimus 1% cream and
hydrocortisone 1% cream in prurigo nodularis and to investigate the mode of action of the
antipruritic effect of the drugs.