Metal Panel Allergen Patch Test Study

NCT04500834 | Unknown Phase 3 FDA Drug

• 1 other identifier: SP20 11MP 301
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Metal allergen patch test study.

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluation of panel adhesion at visit 2 prior to panel removal

  Day 2

• Evaluation of subject reported itching associated with test panels at visit 2 following panel removal

  Day 2

• Evaluation of subject reported burning associated with test panels at visit 2 following panel removal.

  Day 2

• Evaluation of tape irritation

  Day 21

• Evaluation of chip irritation

  Day 21

Study Arms (1)

Positive reactions, Concordance with reference allergen

EXPERIMENTAL

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

Interventions

Metal Panel T.R.U.E. Test BIOLOGICAL

Diagnostic patch test

Positive reactions, Concordance with reference allergen

Eligibility Criteria

• Age: 18 Years - 99 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 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.
• 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.
• 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. Breastfeeding may be resumed upon completion of the study.
• Acute dermatitis outbreak or dermatitis on or near the test area on the back.
• Known or suspected infection of the skin, joints or other site(s) associated with metal exposure
• 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.
• Condition such as; psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma that may confound the evaluation of allergic contact dermatitis.
• 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 (1)

DS Research

Louisville, Kentucky, 40241, United States

RECRUITING

Study Officials

• Curt Hamann, M.D.

  Allerderm (dba SmartPractice)

  STUDY DIRECTOR

Central Study Contacts

Kathryn Shannon

CONTACT

602-225-0595; kshannon@smarthealth.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will be tested with 11 experimental metal allergens and corresponding metal allergens prepared in petrolatum

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 5, 2020
• Study Start: February 7, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)