8 Metal Dose Response Study
- Conditions
- Metal induced contact dermatitisMedDRA version: 19.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2015-002678-19-DE
- Lead Sponsor
- SmartPractice
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
18 years of age or older.
Past positive patch test result within the past 10 years (to one of the dilution series metals being tested on this study) or strong suspicion of metal contact allergy based on results of the Qualification Questionnaire.
Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential;
-Inability to become pregnant would include all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation.
-Acceptable methods of contraception include: 1) systemic birth control (i.e., oral contraceptives, skin patch, vaginal ring, implant, injection, or intrauterine device (IUD), which contains either a hormone or copper); 2) double barrier method (i.e., diaphragm, cervical cap, sponge, condom with spermicide); 3) IUD; 4) vasectomized partner; or 5) abstinence from sexual intercourse. Subject must agree to use acceptable contraception for the duration of the entire study.
(Notes:
*Cervical cap and abstinence from sexual intercourse will not be considered as acceptable methods of contraception for subjects enrolled in Japan
*A double-barrier method must be used for all subjects enrolled in Switzerland who are practicing non-systemic methods of birth control.
*Abstinence from sexual intercourse will not be considered an acceptable method of contraception for subjects enrolled in Switzerland)
Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations.
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study. Breastfeeding may be resumed upon completion of the study.
Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area 14 days prior to inclusion through the end of the subject’s participation in the study.
Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents 14 days prior to inclusion through the end of the subject’s participation in the study. Inhaled treatments and steroidal nose or eye drops are permitted.
Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion through the end of the subject’s participation in the study.
Acute dermatitis outbreak or dermatitis on or near the test area on the back.
Known or suspected infection of the skin, joints or other site(s) associated with metal exposure
Condition such as; fibromyalgia, chronic fatigue, depression, cognitive impairment, flu-like symptoms, diarrhea and/or headache without at least one of the symptoms related to metal exposure listed in Section 10.1 under physical examination.
Condition such as; psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma that may confound the evaluation of allergic contact dermatitis.
Inability to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
Participation in a clinical trial of an investigational drug, treatment or device during this study or 3 weeks prior to inclusion in this study.
An opinion of the Investigator that deems the potential subject to be non-compliant, unable to return for study visits or complete the study as detailed in the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method