Clinical Evaluation of Metal Panel Allergens: Dose Response Study

NCT02615249 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SP148MP201
• Study Type: interventional
• Target: 122
• Locations: 6 countries
• Sites: 8

Brief Summary

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

Conditions

Dermatitis, Eczematous

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Patch Test Responses

  Allergen patch test sites were scored at Visit 3 (day 3-4) Visit 4 (day 7-8) Visit 5 (day 10-14) and Visit 6 Day 19-23). Determination of positive or negative test response for each allergen dose was assessed by the investigator following the final visit.

  21 days post patch application

Secondary Outcomes (3)

• Number of Subjects With Panel Adhesion

  Day 2, visit 2 prior to panel removal

• Tape Irritation

  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

• Chip Irritation

  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

Study Arms (1)

Metal Allergen Epicutaneous Patch

EXPERIMENTAL

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

Biological: Metal Allergen Epicutaneous Patch

Interventions

Metal Allergen Epicutaneous Patch BIOLOGICAL

48 hour application of metal allergen patch to diagnose contact dermatitis

Metal Allergen Epicutaneous Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.)
• Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations.

You may not qualify if:

• Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study.
• Acute dermatitis outbreak or dermatitis on or near the test area on the back.
• 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
• 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).
• 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.

Sponsors & Collaborators

• Allerderm: lead

Study Sites (8)

National Jewish Health, University of Colorado Denver

Denver, Colorado, 80206, United States

Location

Ludwig-Maximilians-Universitat Munchen

Munich, 80337, Germany

Location

University of Milano

Milan, 20161, Italy

Location

Fujita Health University School of Medicine

Aichi, 470-1192, Japan

Location

Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Tokushima University Graduate School

Tokushima, 770-8504, Japan

Location

VU University Medical Center

Amsterdam, NL1081, Netherlands

Location

University Hospital Basel Allergology Unit

Basel, CH-4031, Switzerland

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Kathryn Shannon
• Organization: Allerderm (dba) SmartPractice

kshannon@smartpractice.com

6022250595

Study Officials

• Patricia L Norris, MD

  Oregon Health & Science University, Portland USA

  PRINCIPAL INVESTIGATOR

• Karin Pacheco, MD

  National Jewish Health School of Medicine, Colorado USA

  PRINCIPAL INVESTIGATOR

• Andreas Bircher, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Paolo Pigatto, MD

  University of Milano, Italy

  PRINCIPAL INVESTIGATOR

• Thomas Rustemeyer, MD, PhD

  VU University Medical Center, Netherlands

  PRINCIPAL INVESTIGATOR

• Peter Thomas, MD

  Ludwig-Maximilians-Universität München, Germany

  PRINCIPAL INVESTIGATOR

• Maki Hosoki, DDS, PhD

  Tokushima University Graduate School, Japan

  PRINCIPAL INVESTIGATOR

• Risa Tamagawa-Mineoka, MD

  Kyoto Prefectural University of Medicine, Japan

  PRINCIPAL INVESTIGATOR

• Akiko Yagami, MD, PhD

  Fujita Health University School of Medicine, Japan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 26, 2015
• Study Start: December 5, 2016
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: August 25, 2020
• Results First Posted: August 11, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (1); IT (1); NL (1); US (1); JP (3)