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Anti-IL-17 a New Treatment for Contact Dermatititis

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: NCT02778711
Recruitment Status : Unknown
Verified May 2016 by Tanja Todberg, MD, University of Copenhagen.
Recruitment status was:  Recruiting
First Posted : May 20, 2016
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
Tanja Todberg, MD, University of Copenhagen

Brief Summary:
The purpose of this study is to assess the efficacy of anti-IL 17 treatment (secukinumab) in patients with known severe allergic contact dermatitis (ACD).

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitits Drug: secukinumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-IL-17 a New Treatment for Contact Dermatititis
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Cosentyx
secukinumab (anti-IL-17)
Drug: secukinumab
anti-IL-17
Other Name: Cosentyx




Primary Outcome Measures :
  1. 1. Reduction in clinical patch test score for dermatitis after secukinumab treatment compared to patch test score before treatment (study 1) [ Time Frame: 18 months ]
  2. Reduction in severity of eczema using the PGA score after treatment with secukinumab. [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must be > 18
  • Have a known nickel allergy with at least a +2 reaction when challenged with nickel
  • Patients must have given their informed consent to the protocol and the clinical procedures
  • Be able to speak and understand Danish.
  • Patients must be > 18
  • Have at least two known contact allergies
  • Moderate to severe dermatitis at inclusion (PGA ≥ 3)
  • Failure to local anti-inflammatory treatment and to at least one systemic anti-inflammatory treatment
  • Patients must have given their informed consent to the protocol and the clinical procedures
  • Be able to speak and understand Danish

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
  • Patients who have received any other study medication 4 weeks prior to day 0
  • Dermatitis at the upper inner arm
  • Patients with clinically significant disorders
  • Patients with active TB/serious infections
  • 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, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception.
  • Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study
  • Latex allergy
  • 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
  • Patients who have received any other study medication 4 weeks prior to day 0
  • Patients with clinically significant disorders
  • Patients with active TB/serious infections
  • 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, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception.
  • Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study
  • Latex allergy

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): NCT02778711


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, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02778711    
Other Study ID Numbers: 2015-004494-33
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Keywords provided by Tanja Todberg, MD, University of Copenhagen:
anti-IL-17
secukinumab