View clinical trials related to Prurigo Nodularis.Filter by:
To investigate the anti-pruritic efficacy and safety of Nalbuphine ER (NAL ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER and subjects who received placebo will crossover to NAL ER.
The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor antagonist is safe and effective for treatment of prurigo nodularis versus placebo.
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 50 weeks.
The primary objectives of the study are to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.
This trial will include: - Study period up to 7 months. - Office visits monthly lasting approximately 1 hour. - Blood Draws. - Oral medication that is taken 2 times daily. - Photographs and biopsies if agreed.
Prurigo nodularis (PN) is a common dermatological disorder, manifested as scaly nodules which appear mainly on the extensor surfaces of the limbs. PN may appear secondarily to skin scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. Nevertheless, in many cases no underlying physical disease is present. According to the literature, in fifty percent of the patients there is co-morbidity with depression, anxiety or somatoform disorders. We hypothesize that a group of these patients may benefit from antidepressant therapy.
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.