Clinical trial NCT02615249: Clinical Evaluation of Metal Panel Allergens: Dose Response Study
Official title: Clinical Evaluation of Metal Panel Allergens: Aluminum, Copper, Manganese, Molybdenum, Tin, Titanium, Vanadium and Zinc Dose Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Eczematous
Lead sponsor: Allerderm
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 48-hour application of metal allergen patches to test for potential allergic responses.

Detailed description: A 48-hour application (approximate) of investigational allergen panels, excipient controls and corresponding reference allergens will be applied to the skin of human subjects to test for potential positive allergic responses. Test sites will be evaluated at 3-4, 7-8, 10-14 and 19-23 days after application. Ascending allergen dosages will be randomized within each panel into three different configurations which will be randomly assigned to subjects as they enter the study. The investigators and subjects will be aware of the allergens and the patch test doses but will not be aware of the location of individual allergens within each panel.

Eligibility criteria: 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 includes 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) intrauterine device; 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.

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 in this study.
3. Systemic treatment with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents during the 14 days prior to inclusion in this study. Inhaled treatments are permitted. NOTE: Steroidal nose or eye drops are permitted.
4. Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
5. Acute dermatitis outbreak or dermatitis on or near the test area on the back.
6. 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
7. 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).
8. Participation in a clinical trial of an investigational drug, treatment or device during this study or 3 weeks prior to inclusion in this study.
9. 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.

Primary outcomes:
measure: Number of Participants With Patch Test Responses
timeFrame: 21 days post patch application
Secondary outcomes:
measure: Number of Subjects With Panel Adhesion
timeFrame: Day 2, visit 2 prior to panel removal
measure: Tape Irritation
timeFrame: Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6
measure: Chip Irritation
timeFrame: Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health, University of Colorado Denver
state: Colorado
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universitat Munchen
city: Milan
country: Italy
facility: University of Milano
city: Aichi
country: Japan
facility: Fujita Health University School of Medicine
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Tokushima
country: Japan
facility: Tokushima University Graduate School
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Basel
country: Switzerland
facility: University Hospital Basel Allergology Unit
Study officials:
affiliation: Oregon Health & Science University, Portland USA
name: Patricia L Norris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Jewish Health School of Medicine, Colorado USA
name: Karin Pacheco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Andreas Bircher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milano, Italy
name: Paolo Pigatto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VU University Medical Center, Netherlands
name: Thomas Rustemeyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig-Maximilians-Universität München, Germany
name: Peter Thomas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokushima University Graduate School, Japan
name: Maki Hosoki, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto Prefectural University of Medicine, Japan
name: Risa Tamagawa-Mineoka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujita Health University School of Medicine, Japan
name: Akiko Yagami, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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