Prurigo Nodularis Clinical Trial
Official title:
Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis
Verified date | July 2018 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the anti-pruritic effect of apremilast in patients with known PN.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 1, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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® |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Dermato-Allergology | Hellerup |
Lead Sponsor | Collaborator |
---|---|
Tanja Todberg, MD |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast | 1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast | 12 weeks |
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