MedPath

Anti-IL-17, a possible new treatment for contact dermatitis?

Phase 1
Conditions
allergic contact dermatitis
MedDRA version: 18.1Level: LLTClassification code 10056265Term: Allergic contact dermatitisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Registration Number
EUCTR2015-004494-33-DK
Lead Sponsor
Herlev and Gentofte Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

Study1
Main criteria for inclusion
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.

Study2
Main criteria for inclusion
Patients must be > 18
Have at least two known contact allergies
Moderate to severe dermatitis at inclusion
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Study 1
Main criteria for exclusion
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
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.
Pregnancy
Nursing
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

Study2
Main criteria for exclusion
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
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.
Pregnancy
Nursing
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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath