Metal Allergen Patch Test

Phase 1

• Conditions: Diagnosis of Allergic Contact Dermatitis; MedDRA version: 20.0Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-005459-18-IT
• Lead Sponsor: SMARTPRACTICE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-25
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

a.18 years of age or older.
b.History of contact dermatitis;
c.Positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride hexahydrate, aluminum hydroxide and/or aluminum lactate), 3) palladium (sodium tetrachloropalladate and/or palladium chloride), and/or 4) itching, subcutaneous nodules or excoriated papules at the sites of vaccination injections within the past 10 years;
d.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; 2) double barrier method (condom with spermicide or diaphragm 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.
e.Has understood and signed the approved Informed Consent/Assent Form, which is consistent with all institutional, local and national regulations. Assent Form for all minor subjects (ages 15-17) must be signed by the guardian/parent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

a.Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant for the course of the study.
b.Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 7 days prior to inclusion in this study.
c.Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents during the 7 days prior to inclusion in this study. Inhaled treatments are permitted.
d.Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
e.Acute dermatitis outbreak or dermatitis on or near the test area on the back.
f.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).
g.Participation in a clinical trial of an investigational drug, treatment or device other than T.R.U.E. TEST¿ during this study or 3 weeks prior to inclusion in this study.
h.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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified