Clinical Evaluation of Metal Panel Allergens: Dose Response Study

NCT ID: NCT02615249

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2019-07-15

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.

Conditions

Dermatitis, Eczematous

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Metal Allergen Epicutaneous Patch

8 allergens were tested. Not all subjects tested each allergen. Section reports number of subjects with positive responses to each allergen.

Group Type: EXPERIMENTAL

Metal Allergen Epicutaneous Patch

Intervention Type: BIOLOGICAL

48 hour application of metal allergen patch to diagnose contact dermatitis

Interventions

Metal Allergen Epicutaneous Patch

48 hour application of metal allergen patch to diagnose contact dermatitis

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia L Norris, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health & Science University, Portland USA

Karin Pacheco, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health School of Medicine, Colorado USA

Andreas Bircher, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Paolo Pigatto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milano, Italy

Thomas Rustemeyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VU University Medical Center, Netherlands

Peter Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians-Universität München, Germany

Maki Hosoki, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokushima University Graduate School, Japan

Risa Tamagawa-Mineoka, MD

Role: PRINCIPAL_INVESTIGATOR

Kyoto Prefectural University of Medicine, Japan

Akiko Yagami, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fujita Health University School of Medicine, Japan

Locations

National Jewish Health, University of Colorado Denver

Denver, Colorado, United States

Ludwig-Maximilians-Universitat Munchen

Munich, , Germany

University of Milano

Milan, , Italy

Fujita Health University School of Medicine

Aichi, , Japan

Kyoto Prefectural University of Medicine

Kyoto, , Japan

Tokushima University Graduate School

Tokushima, , Japan

VU University Medical Center

Amsterdam, , Netherlands

University Hospital Basel Allergology Unit

Basel, , Switzerland

Countries

United States; Germany; Italy; Japan; Netherlands; Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SP148MP201

Identifier Type: -

Identifier Source: org_study_id