Metal Panel Allergen Patch Test Study

Last updated: February 10, 2023
Sponsor: Allerderm
Overall Status: Active - Recruiting

Phase

3

Condition

Eczema (Atopic Dermatitis - Pediatric)

Rash

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT04500834
SP20 11MP 301
  • Ages 18-99
  • All Genders

Study Summary

Metal allergen patch test study.

Eligibility Criteria

Inclusion

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 metalcontact allergy based on results of the Qualification Questionnaire, part 2 Type ofMetal Exposure.
  3. Unable to become pregnant or willing to use an acceptable method of contraception toprevent pregnancy if female of childbearing potential,
  • Inability to become pregnant would include all male subjects and female subjectswho are postmenopausal for at least 1 year, or surgically sterile- have had ahysterectomy, bilateral ovariectomy, uterine ablation or bilateral tuballigation.
  • Acceptable methods of contraception include: 1) systemic birth control (i.e.,oral contraceptives, skin patch, vaginal ring, implant, injection, orintrauterine device (IUD), which contains either a hormone or copper); 2) doublebarrier method (i.e., diaphragm, cervical cap, sponge, condom with spermicide);
  1. IUD; 4) vasectomized partner; or 5) abstinence from sexual intercourse.Subject must agree to use acceptable contraception for the duration of the entirestudy.
  1. Understands and signs the approved Informed Consent form which is consistent with allinstitutional, local and national regulations.

Exclusion

Exclusion Criteria:

  1. Breastfeeding or pregnant (as determined by urine pregnancy test) or intending tobecome pregnant during the course of the study. Breastfeeding may be resumed uponcompletion of the study.
  2. Topical treatment with corticosteroids or other immunosuppressive agents on or nearthe test area 14 days prior to inclusion through the end of the subject'sparticipation in the study.
  3. Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or otherimmunosuppressive agents 14 days prior to inclusion through the end of the subject'sparticipation in the study. Inhaled treatments and steroidal nose or eye drops arepermitted.
  4. Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior toinclusion 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 withmetal exposure
  7. Condition such as; fibromyalgia, chronic fatigue, depression, cognitive impairment,flu-like symptoms, diarrhea and/or headache without at least one of the symptomsrelated to metal exposure listed in Section 6.6.
  8. Condition such as; psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneousT-cell lymphoma that may confound the evaluation of allergic contact dermatitis.
  9. Inability to comply with patch test study requirements including multiple returnvisits and activity restrictions (e.g., protecting test panels from excess moisturedue to showering or vigorous activity).
  10. Participation in a clinical trial of an investigational drug, treatment or deviceduring 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

Total Participants: 200
Study Start date:
February 07, 2022
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • DS Research

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

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