Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2022-02-07
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Metal Panel T.R.U.E. Test
Diagnostic patch test
Interventions
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Metal Panel T.R.U.E. Test
Diagnostic patch test
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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Allerderm
INDUSTRY
Responsible Party
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Principal Investigators
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Curt Hamann, M.D.
Role: STUDY_DIRECTOR
Allerderm (dba SmartPractice)
Locations
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DS Research
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SP20 11MP 301
Identifier Type: -
Identifier Source: org_study_id
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