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Clinical Trial Details for Clinical Evaluation of Metal Panel Allergens: Dose Response Study


Allerderm
NCT ID: NCT02615249
Last Updated: April 6, 2018

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 18 Years - N/A
  • Condition: Dermatitis, Eczematous
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Allerderm
  • Location: Not Provided

Official Title

Clinical Evaluation of Metal Panel Allergens: Aluminum, Copper, Manganese, Molybdenum, Tin, Titanium, Vanadium and Zinc Dose Response Study

Purpose

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

Eligibility

Ages Eligible for Study

18 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Allerderm

Investigators

Principal Investigator: Patricia L Norris, MD

Oregon Health & Science University, Portland USA

Please refer to this study by its ClinicalTrials.gov identifier: NCT02615249

Location

Contacts

National Jewish Health, University of Colorado Denver

Denver, Colorado 80206

United States

Karin Pacheco, MD

pachecok@njhealth.org

Oregon Health & Science University

Portland, Oregon 97239

United States

Ludwig-Maximilians-Universitat Munchen

Munich, 80337

Germany

University of Milano

Milan, 20161

Italy

Paolo Pigatto, MD

pigatto@pigattobersani.it

Fujita Health University School of Medicine

Aichi, 470-1192

Japan

Akiko Yagami, Md, PhD

ayagami@fujita-hu.ac.jp

Kyoto Prefectural University of Medicine

Kyoto, 602-8566

Japan

Risa Tamagawa-Mineoka, MD

risat@koto.kpu-m.ac.jp

Tokushima University Graduate School

Tokushima, 770-8504

Japan

Maki Hosoki, DDS

hosoki@tokushima-u.ac.jp

VU University Medical Center

Amsterdam, NL1081

Netherlands

Thomas Rustemeyer, MD, PhD

trustemeyer@vumc.nl

University Hospital Basel Allergology Unit

Basel, CH-4031

Switzerland

Andreas Bircher, MD

andreas.bircher@usb.ch