True Test Panel 1

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

TRUE Test

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Panel 1	1.	Active Ingredient Nickel sulphate	Labelled amount Micrograms/ cm² 200	Micrograms/ patch 160
	2.	Wool alcohols	1000	810
	3.	Neomycin sulphate	230	190
	4.	Potassium dichromate	23	19
	5.	Caine mix¹	630	510
	6.	Fragrance mix²	430	350
	7.	Colophony	850	690
	8.	Epoxy resin	50	41
	9.	Quinoline mix³	190	154
	10.	Balsam of Peru	800	650
	11.	Ethylenediamine	50	41
	12.	dihydrochloride Cobalt Chloride	20	16
Panel 2	13.	p-tert Butylphenol	50	41
	14.	formaldehyde resin Paraben mix⁴	1000	800
	15.	Carba mix^{5 6}	250	204
	16.	Black rubber mix®	75	60
	17.	Cl+ Me-lsothiazolinone	4	3.2
	18.	(Kathon CG) Quaternium-15	100	81
	19.	Mercaptobenzothiazole	75	61
	20.	p-Phenylenediamine	90	73
	21.	Formaldehyde ^g)	180	150
	22.	Mercapto mix^h)	75	60
	23.	Thiomersal	8	6.5
	24.	Thiuram mix®	25	20

e) Equal weights of diphenylguanidine, zincdiethyldithiocarbamate and zincdibutyldithiocarbamate.

f) Two parts of N-isopropyl-N’-phenyl paraphenylenediamine, five parts of N-cyclohexyl-N’-phenyl paraphenylenediamine and five parts of N,N’-diphenyl paraphenylenediamine.

g) Actually contains N-hydroxymethyl succinimide.

h) Equal weights of morpholinylmercaptobenzothiazole, N-cyclohexylbenzothiazylsulphenamide and dibenzothiazyl disulphide.

i) Equal weights of disulfiram, dipentamethylenethiuram disulphide, tetramethylthiuram disulphide and tetramethylthiuram monosulphide.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Plaster for provocation test.

TRUE Test consists of 2 panels of surgical plaster each with 12 patches containing 12 different commonly occurring contact allergens. Each patch is coated with a film containing the test substance.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

This medicinal product is for diagnostic use only.

TRUE Test is indicated for investigation of patients with a history of dermatitis and a suspicion of having contact allergy and/or allergic contact dermatitis.

4.2 Posology and method of administration

Open the package and remove the test panel.

Remove the protective plastic from the test surface of the panel. Be careful not to touch the test substances.

Position the test on the patient's back - the outer part of the upper arm can eventually be used. Smooth gently outward toward the edges, making sure each allergen makes firm contact with the skin. The 2 panels may be placed on each side a few cm from the midline of the back.

Indicate on the skin the location of the two notches on each panel with a medical marking pen.

The patient must wear TRUE Test for a minimum of 2 days without removing it and being careful not to get the test area wet (water, sweat).

Following this period, the test is removed either by the physician or the patient.

Interpretation

The reaction should be read 1/2 an hour after removal of the test and again 1-2 days after removal, when the allergic reactions are fully developed and mild irritant reactions have faded.

Neomycin sulphate and p-phenylenediamine, however sometimes cause reactions, which may not appear until 4-5 days after the application. Patients should be instructed to report this. If appropriate, an additional office visit will verify a delayed reaction.

An identification template is provided with each package of TRUE Test for quick identification of any allergen, which causes a reaction. To assure correct positioning, marks on the skin should correlate with the notches on the template. Notice the difference between page 1 and 2 on the template corresponding to panel 1 and 2.

The interpretation method recommended by the International Contact Dermatitis Research Group is:

- negative reaction

? doubtful reaction; faint macular erythema, none or insignificant infiltration + Weak (nonvesicular) positive reactions are characterized by all or several of the following symptoms: Pruritus, burning sensation, erythema, swelling, weak infiltration, and possible papules.

++ Strong (vesicular) positive reactions are characterized by all or several of the following symptoms: Pruritus, burning sensation, erythema, swelling, infiltration, papules, and vesicles.

++ Extreme positive reactions are characterized by all or several of the + following symptoms: Pruritus, burning sensation, pronounced erythema,

swelling, infiltration, bullous or ulcerative reactions, and coalescing vesicles.

IR irritant reaction of different types NT Not tested

Note

Patients showing a negative reaction may still be sensitised to another substance not included in this test panel. Furthermore, false-negative results may occur. Retesting or testing with complementary substances may be indicated.

A positive reaction (+, ++, +++) should meet the criteria for an allergic reaction (papular or vesicular erythema and infiltration).

Pustules, as well as patchy follicular or homogeneous erythema without infiltration are usually signs of unspecific skin irritation, - but may also indicate a mild contact allergy. This can only be evaluated by careful patient history in combination with the clinical picture. Repeated patch tests may be helpful in the interpretation.

What is important in the evaluation of a positive test response is not the number of plusses assigned to the skin reaction, but determining whether the response is a truly positive allergic reaction or a non-specific irritant reaction, and whether the positive reaction has a clinical relevance to the patient's dermatitis.

Paediatric use :

The safety and effectiveness of TRUE Test in children has not been established.

4.3 Contraindications

Acute dermatitis. Testing should be postponed until the acute course has past.

4.4 Special warnings and precautions for use

TRUE Test contains environmental substances known to cause allergic (type IV) contact dermatitis, and the test is indicated for testing for type IV allergies in patients where different environmental factors are expected to play a role in the development of their reactions.

TRUE Test is not indicated for testing for type I allergies, i.e. anaphylactic reactions, urticaria or other immediate type reactions. Testing for type I allergies requires other types of diagnostic tests, i.e. skin prick tests and blood tests. If patients with a known history of anaphylactoid reactions are tested they should be carefully evaluated before application of TRUE Test.

Sensitisation to a substance on the test panel due to the test procedure only seldom occurs. A test reaction that appears later than day 10 may be a sign of contact sensitisation.

Excited back/skin syndrome (“angry back”) is a state of skin hyper-reactivity induced by dermatitis on other parts of the body or by a strong positive skin test reaction, and may give rise to false positive tests. Therefore, test results should be evaluated carefully in patients with multiple, positive, concomitant patch test results. If false positive tests are suspected, retesting at a later date may be indicated.

Testing with TRUE Test should not be done when the patient has widespread dermatitis, and testing should be postponed until the dermatitis is in a quiet phase, because of the risk of unspecific, interfering reactions as “angry back” (see above) which hamper interpretation of the test result (see section 4.3, “Contraindications”).

Extremely sensitive patients may experience extreme positive (3+) reactions defined by all or several of the following symptoms: Pruritus, burning sensation, pronounced erythema, swelling, infiltration, bullous or ulcerative reactions, and coalescing vesicles. Extreme positive reactions are also described in section 4.2, “Interpretation”.

Delayed positive reactions may occur at 7 to 10 days after application of the panel. A "late reaction" after day 10 may be interpreted at a sign of patch test sensitization - but may also be a "delayed positive reaction" of a previously documented contact allergy. This can only be interpreted by careful consideration of the clinical history and the characteristics of the patient's dermatitis.

Excessive sweating and sun exposure of the test site should be avoided.

Avoid applying the test on skin with acne, scars, dermatitis or any other condition that may interfere with test results.

If a severe patch test reaction develops, the test reaction may be treated with a topical corticosteroid. In very rare cases treatment with systemic corticosteroids may be indicated.

4.5 Interaction with other medicinal products and other forms of interaction

Steroids may suppress a positive test reaction. Use of topical steroids on the test site or oral steroids (equivalent to 10mg of prednisolone or more on a daily basis) should be discontinued for two weeks prior to testing.

4.6 Fertility, pregnancy and lactation

Should not be used. Experience limited.

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

The most frequently occurring adverse reaction with TRUE Test is unspecified tape reaction. This adverse reaction is seen in more than 1 out of 10 patients (see table below). The rest of the adverse reactions occurring with TRUE Test are also listed in the table along with the estimated frequencies.

System organ classes	Frequency	Undesirable effect
Skin and subcutaneous tissue disorders	Very common (>1/10)	- Unspecified tape reaction - Long-lasting reaction
	Common (>1/100 to <1/10)	- Skin hypopigmentation/ hyperpigmentation
	Uncommon (>1/1,000 to <1/100)	- Flare-up of previous dermatitis
	Rare (>1/10,000 to <1/1,000)	- Sensitisation

Unspecified tape reaction

Unspecified tape reactions can be characterised by one or more of the following symptoms: Pruritus, burning sensation, erythema, papules and swelling, at the place where the tape is placed or has been placed.

Long-lasting reaction

Long-lasting reactions are positive reactions at days 2 - 7 that may remain visible for weeks or in rare cases for months.

Skin hypopigmentation/hyperpigmentation

Positive test reaction may leave an area of transient hypopigmentation/ hyperpigmentation at application site.

Flare-up of previous dermatitis

Flare up can be seen at skin sites of previous contact dermatitis (recall reactions). Flare-up is more prone in patients with multiple allergies (three or more allergies in one patient).

Sensitisation

Rarely, sensitisation to a substance on the test panel may occur with patch testing. A negative patch test reaction, followed by a positive reaction later than 10 days from panel application, may indicate active sensitisation. Active sensitisation is confirmed upon retesting with a positive reaction occurring early at the 2 to 4 days reading.

4.9 Overdose

Not applicable

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: V 04 CL

A positive response to the patch test is a classical delayed hypersensitivity reaction (type IV), which can appear within 6 hours to 7 days after exposure.

The cell-mediated response involves the Langerhans' cell and T-lymphocytes, which interact and produce lymphokines. These lymphokines then form lymphocyte clones with trigger macrophages to cause a cutaneous inflammation.

Clinical signs of a positive contact dermatitis reaction are: erythema, infiltration, oedema, papules and vesicles at the test area.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Preclinical data do not indicate a risk for acute toxicity. Some of the substances (nickel sulphate, potassium dichromate, cobalt chloride, epoxy resin and thiuram mix) have shown carcinogenic potential in animal studies. Nevertheless, these findings do not represent a significant additional risk for the clinical use of TRUE Test taking into consideration dose levels, time of exposure and/or other modes of exposure to the same substances.

6 PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Besides the active substances, stated under Section 2 the test contains the following excipients: Plaster of cellulose acetate with acrylic adhesive, Polyester patches, Polyvidone (vehicle), Hydroxypropyl cellulose (vehicle), Methyl cellulose (vehicle), B-Cyclodextrin (stabilizer), Sodium carbonate (buffer) and Sodium bicarbonate (buffer).

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store in a refrigerator (2-8°C)

6.5 Nature and contents of container

Each panel is covered by a protective sheet of silicone-treated polyethylene and then packed in airtight pouches of packaging laminate.

For stabilization purposes, panel 2 contains a desiccant paper.

Pack size: Carton box with 10 test units (1 unit = one panel 1 and one panel 2), reading template and patient information leaflet.

6.6 Special precautions for disposal and handling

No special requirements

7 MARKETING AUTHORISATION HOLDER

SMARTPRACTICE DENMARK ApS

Herredsvejen 2

DK- 3400

Hillerod

Denmark

8 MARKETING AUTHORISATION NUMBER(S)

PL 19095/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/03/2004

10 DATE OF REVISION OF THE TEXT

06/03/2013

Five parts of benzocaine, one part of cinchocaine hydrochloride and tetracaine hydrochloride.

Five parts of geraniol and oak moss, four parts of hydroxycitronellal and cinnamylalcohol, two parts of cinnamaldehyde and eugenol and one part of isoeugenol and a-amylcinnamaldehyde.

Equal weights of clioquinol and chlorquinaldol.

Equal weights of methyl parahydroxybenzoate, ethyl parahydroxybenzoate propyl

parahydroxybenzoate, butyl parahydroxybenzoate and benzyl

parahydroxybenzoate.