Recruiting
Phase 3

Allergen Patch Test

Sponsor:

Allerderm

Code:

NCT04500834

Conditions

Atopic Dermatitis Eczema

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Metal Panel T.R.U.E. Test

Study Details

Brief summary:

Metal allergen patch test study.

Conditions

Atopic Dermatitis Eczema

Study ID

NCT04500834

Start date

Feb 7, 2022

Status verified date

Feb, 2023

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Metal Panel T.R.U.E. Test

Diagnostic patch test

Primary outcome measure

  • Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens [ Time Frame: Days 3-21 ]

Central Contacts and Locations

Central contacts

Locations

DS Research

Recruiting

Louisville, Kentucky, United States, 40241

Contacts

Principal Investigator:

Joseph Fowler, MD

More Information

Sponsor

Allerderm

Last update posted

Feb 13, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allerderm on 2023-02-13.