Prurigo Nodularis Clinical Trial
Official title:
Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis
This study will evaluate the anti-pruritic effect of apremilast in patients with known PN.
Prurigo nodularis(PN) is a chronic skin disease, characterized by severe pruritus, multiple
hyperkeratotic nodules and papules often located on the extensor part of the upper and lower
extremities with a symmetrical distribution. The disease often appears between 20-60 years of
age affecting men and women equally.
The pathogenesis of PN is poorly understood and it is unknown whether PN is a primary
dermatological disease or if it arises secondary to intense pruritus and scratching of the
skin with other diseases being the cause of the itching.
A number of studies have investigated if certain biochemical parameters are involved in
mediating PN e.g. studies have indicated that the small nerve fibres in dermis in lesioned
skin have an increased density of Substance P (neuropeptide and a well-known mediator of
pruritus. when compared to non-lesioned skin.Other studies have suggested that patients with
PN have a high presence of nerve growth factor (NGF) in dermis leading to modulation of the
small nerve fibres, as well as an increased number of eosinophilic granulocytes, mast- and
Merkel cells. Additionally, studies have found increased levels of IL-6 and IL-31 in blood in
patient with PN. However the pathogenesis of PN remains unknown.
Among patients with atopic dermatitis there is a higher frequency of patients with PN as well
as PN seem to be associated with certain liver- and kidney diseases. Anxiety and depression
are also more common in patients with PN.
Patients with PN suffer from impaired quality of life due to ongoing pruritus and skin
lesions(5). PN is mainly treated with topical steroids, UVB, PUVA or thalidomide, although
none of these treatments seem to be able to control the disease and furthermore a number of
these treatments are associated with several side effects.
As the phosphodiesterase 4 (PDE4)-inhibitor (apremilast) have shown a , it is speculated that
apremilast may have an effect in patients with PN. Lack of effective treatments for PN
supports further development for treatment options.
This study will evaluate the anti-pruritic effect of apremilast in patients with known PN.
This interventional study, will be performed at the Department of Dermatology and Allergy at
Herlev and Gentofte Hospital (Gentofte site), University of Copenhagen, Hellerup, Denmark.
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