Metal Panel Patch Test

Status Not authorised · 3 EU/EEA countries · 5 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Not authorised

Participants planned 300

Countries 3

Sites 5

Allergic contact dermatitis Eczema

The objective of this study is to evaluate the diagnostic efficacy and safety of the investigational allergens and overall safety and performance of the investigational panel device constituent.

Key facts

Sponsor: Smarthealth Inc.
Participant type: Healthy volunteers, Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Decision date (initial): 2024-01-22
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: SmartPractice

External identifiers

EU CT number: 2023-507972-35-00
ClinicalTrials.gov: NCT04500834

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Diagnosis

The objective of this study is to evaluate the diagnostic efficacy and safety of the investigational allergens and overall safety and performance of the investigational panel device constituent.

Conditions and MedDRA coding

Allergic contact dermatitis Eczema

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Entire Study All enrolled subjects will be patch tested with all products.	Randomised Controlled	Double	[{"id":39315,"code":1,"name":"Subject"},{"id":39316,"code":3,"name":"Monitor"},{"id":39317,"code":2,"name":"Investigator"}]	Diseased population: Subjects with suspicion of metal allergy Healthy population: Subjects with no history or suspicion of metal allergy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

a. 18 years of age or older
b. Group 1: Active dermatitis that is suspected to be allergic contact dermatitis to one or more of the metal panel allergens or a recent history (within the past 5 years) of dermatitis that is suspected to be due to metal allergy, and that resolved prior to enrollment due to treatment or elimination of exposure to the suspected metal trigger. Population may include individuals with suspected allergic contact dermatitis due to a positive patch test within the preceding 10 years and/or a metal implant. Group 2: No history or symptoms of dermatitis related skin disease.
c. Group 2 only: No past or current body piercings, dental appliances, braces, fillings, implants, prosthesis or restorations, surgical hardware, orthopedic implants or cardiac implants.
d. Group 2 only: No routine occupational or long term exposure to metals
e. Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential
f. Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations

Exclusion criteria 18

a. Participation in Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study, SP12 2PM2 201, or Clinical Evaluation of Metal Panel Allergens: Aluminum, Copper, Manganese, Molybdenum, Tin, Titanium, Vanadium and Zinc Dose Response Study, SP14 8MP 201.
b. 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
c. 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.
d. 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.
e. 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.
f. Acute dermatitis outbreak or dermatitis on or near the test area on the back.
g. Known or suspected infection of the skin, joints or other site(s) associated with metal exposure
h. 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.
i. Condition such as, psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma that may confound the evaluation of allergic contact dermatitis.
j. 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).
k. Participation in a clinical trial of an investigational drug, treatment or device during this study or 3 weeks prior to inclusion in this study.
l. 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.
m. Alcohol abuse as well as drug and/or medication abuse. GERMANY ONLY
n. Severe psychiatric, psychological or neurological disorders. GERMANY ONLY
o. Patients in any relationship or dependency with the sponsor and/or investigator. GERMNY ONLY
p. General inflammatory as well severe acute and chronic inflammatory diseases. GERMANY ONLY
q. Malignancy during the previous 5 years. GERMANY ONLY
r. Completed or ongoing long-term treatment with tranquilizer or psycho active drug.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Concordance (agreement) between the hydrogel (investigational allergen) and petrolatum (reference allergen) patch testing methods using Cohen’s kappa calculation and by positive and negative percent agreement.