Metal Panel Allergen Patch Test Study

Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study

Metal allergen patch test study.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis Eczema
• Intervention / Treatment: Biological: Metal Panel T.R.U.E. Test

Detailed Description

A single application of an investigational patch test panel containing 11 hydrogel metal allergens and a corresponding patch test panel containing 11 petrolatum metal allergens will be applied to the upper back of human subjects to test diagnostic efficacy and safety. Patch test panels will be removed after being worn for approximately 48 hours. Study will require 6 visits over the course of 21 days; patch application, patch removal and 4 patch test site evaluation visits at days 4, 7, 14 and 21.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kathryn Shannon; Phone Number: 602-225-0595; Email: kshannon@smarthealth.com

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Recruiting
      • DS Research
      • Contact: Haley Jordon; Phone Number: 158 502-585-9708; Email: hjordon@dsrtrials.com
      • Principal Investigator: Joseph Fowler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years of age or older.
2. Past positive patch test result within the past 10 years to one of the metal allergens (other than nickel or gold), being tested on this study or strong suspicion of metal contact allergy based on results of the Qualification Questionnaire, part 2 Type of Metal Exposure.

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 (i.e., oral contraceptives, skin patch, vaginal ring, implant, injection, or intrauterine device (IUD), which contains either a hormone or copper); 2) double barrier method (i.e., diaphragm, cervical cap, sponge, condom with spermicide); 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.

Exclusion Criteria:

1. Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study. Breastfeeding may be resumed upon completion of the study.
2. Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area 14 days prior to inclusion through the end of the subject's participation in the 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 the subject's participation in the 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. Condition 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 6.6.
8. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Positive reactions, Concordance with reference allergen; All subjects will be patch tested with 11 experimental and 11 reference allergens. Rates of positive reactions will be evaluated using Cohen's kappa calculation.	Biological: Metal Panel T.R.U.E. Test; Diagnostic patch test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens	Number of patch test responses will be recorded, concordance between hydrogel and petrolatum allergens will be measured	Days 3-21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of panel adhesion at visit 2 prior to panel removal	Number of subjects with excellent, good, poor or detached adhesion at panel removal	Day 2
Evaluation of subject reported itching associated with test panels at visit 2 following panel removal	Number of subjects with no (none) weak, moderate or strong itching associated with test panels following panel removal	Day 2
Evaluation of subject reported burning associated with test panels at visit 2 following panel removal.	Number of subjects with no (none) weak, moderate or strong burning associated with test panels following panel removal	Day 2
Evaluation of tape irritation	Number of subjects with no (none) irritant or allergic tape irritation. Tape irritation is assessed at all visits. Investigator makes overall determination on day 21.	Day 21
Evaluation of chip irritation	Number of subjects with no (none) irritant or allergic chip irritation. Chip irritation is assessed at all visits. Investigator makes overall determination on day 21.	Day 21

Collaborators and Investigators

• Sponsor: Allerderm
• Investigators: Study Director: Curt Hamann, M.D., Allerderm (dba SmartPractice)

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 7, 2022
• Primary Completion (ANTICIPATED): March 31, 2025
• Study Completion (ANTICIPATED): March 31, 2025

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (ACTUAL): August 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: SP20 11MP 301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No