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Trial record 3 of 18 for:    prurigo nodularis

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
Sponsor:
Information provided by (Responsible Party):
Tanja Todberg, MD, University of Copenhagen

Brief Summary:
This study will evaluate the anti-pruritic effect of apremilast in patients with known PN.

Condition or disease Intervention/treatment Phase
Prurigo Nodularis Drug: Apremilast Oral Product Phase 1 Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: apremilast
apremilast standard doses
Drug: Apremilast Oral Product
Apremilast




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years of age
  • PN verified diagnosis by characteristic clinical features
  • Moderate to severe PN
  • Failure of local steroid and light treatment to control disease and symptoms.
  • Be able to speak and understand Danish.
  • Patients must have given their informed consent to the protocol and to the clinical procedures.

Exclusion Criteria:

  • Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0
  • Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0 or 5 pharmacokinetic half-lives, whichever is longer
  • Patients who have received any other study medication 4 weeks prior to day 0
  • Patients with other clinically significant disorders
  • Patients with active TB/serious infections
  • Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol. Patients with previous endogene depression.
  • Pregnancy
  • Nursing
  • Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring og sterilization.

    • Occlusive cap or condom with spermicidal cream is not considered as an effective contraception. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception.
  • Patients who have received any live vaccines 6 weeks prior to day 0 or who are planning to receive a live vaccine during the study
  • Allergy to apremilast or any of the other ingredients in Otezla®

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Dermato-Allergology Recruiting
Hellerup, Denmark, 2900
Contact: Tanja Todberg, MD    0045 38673207    tanja.todberg@regionh.dk   
Sponsors and Collaborators
Tanja Todberg, MD
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Responsible Party: Tanja Todberg, MD, MD, principal investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03576287    
Other Study ID Numbers: 2016-003018-29
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tanja Todberg, MD, University of Copenhagen:
apremilast
Additional relevant MeSH terms:
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Prurigo
Neurodermatitis
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents