Metal Allergen Dose Response Trial

Phase 1

• Conditions: Allergic Contact Dermatitis; MedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2015-002678-19-IT
• Lead Sponsor: SMARTPRACTICE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-07-15
• Study Start: 2022-01-21
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1) 18 years of age or older.
2) 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.
3) 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; 2) double barrier method; 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.)
4) 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

Exclusion Criteria

1) Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study.
2) Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 14 days prior to inclusion through the end of this study.
3) 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.
4) Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion through the end of this study.
5) Acute dermatitis outbreak or dermatitis on or near the test area on the back.
6) Known or suspected infection of the skin, joints or other site(s) associated with metal exposure
7) Conditions 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
8) A condition such as; psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma that may confound the evaluation of allergic contact dermatitis.
9) 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).
10) Participation in a clinical trial of an investigational drug, treatment or device during this study or 3 weeks prior to inclusion in this study.
11) 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