Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03576287|
Recruitment Status : Unknown
Verified July 2018 by Tanja Todberg, MD, University of Copenhagen.
Recruitment status was: Recruiting
First Posted : July 3, 2018
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prurigo Nodularis||Drug: Apremilast Oral Product||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
apremilast standard doses
Drug: Apremilast Oral Product
- 1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast [ Time Frame: 12 weeks ]1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576287
|Department of Dermato-Allergology||Recruiting|
|Hellerup, Denmark, 2900|
|Contact: Tanja Todberg, MD 0045 38673207 firstname.lastname@example.org|