RECRUITING

Metal Panel Allergen Patch Test Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Metal allergen patch test study.

Official Title

Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study

Quick Facts

Study Start:2022-02-07

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04500834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Kathryn Shannon

CONTACT

602-225-0595

kshannon@smarthealth.com

Principal Investigator

Curt Hamann, M.D.

STUDY_DIRECTOR

Allerderm (dba SmartPractice)

Study Locations (Sites)

DS Research

Louisville, Kentucky, 40241

United States

Collaborators and Investigators

Sponsor: Allerderm

Curt Hamann, M.D., STUDY_DIRECTOR, Allerderm (dba SmartPractice)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-07

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2022-02-07

Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis Eczema