True Test 36 – patient leaflet, side effects, dosage

1. What TRUE Test 36 is and what it is used for

TRUE Test 36 is used to test for allergic contact dermatitis. Contact dermatitis is a skin reaction caused by exposure to foreign substances resulting in an allergic reaction.

TRUE Test 36 is a ready-to-use patch test for deter-mining the cause of allergic contact dermatitis. TRUE Test 36 is for use in adults.

The test consists of 3 strips of surgical tape. The strips contains each 12 patches. Each patch is coated with a film containing a substance which might cause a skin reaction in sensitive people. Such substances are called allergens. Each patch contains a different allergen as well as one blank patch TRUE Test 36 contains 35 of the most com-mon allergens/allergen mixes as well as one blank patch.

TRUE Test 36 works by showing if you are allergic to any of the test substances (allergens) on the patches. If a substance to which you are allergic comes into contact with your skin it causes an inflammatory reaction called contact dermatitis.

These substances could be an ingredient in your perfume or aftershave, in an ointment or cream, rub-ber gloves, industrial chemicals, etc. The substances in TRUE Test 36 are well-known allergens. If you are allergic to the substance in a particular TRUE Test 36 patch, then the skin under that patch will react to it, becoming red and inflamed. If you are not allergic to a particular patch, the skin under it will not react. You may be allergic to more than one patch.

2. What you need to know before you use TRUE Test 36

Do not use TRUE Test 36:

• If you suffer from severe or generalized dermati-tis. The testing should be delayed until the acute course of dermatitis is over.

• If you are allergic to any of the other excipients in TRUE Test 36 (listed in section 6).

  Warnings and precautions

  You should avoid exposing the test area to the sun. Suntan may cause you to miss positive reactions to allergens you are actually allergic to.

  • avoid sweating profusely while wearing the patch test strips.
  • if you are taking medicines suppressing your immune system such as steroid medicines (e.g. prednisolone) or using steroid ointments/creams (e.g. hydrocortisone). These should not be used for at least two weeks before the test.
  • if you have excited skin syndrome (angry back). This is a state of skin over-irritability caused by a reaction on other parts of the body. If you react to all of the patches, the doctor may need to repeat the test another day.
  • If you have earlier had anaphylactoid reactions, the use of TRUE Test 36 should be considered carefully.

Talk to your doctor before using TRUE Test 36 if any of these factors apply to you. Your doctor will be able to decide what to do.

Sensitisation: In rare instances you may become sensitive to a substance on the patches while using TRUE Test 36. A test reaction that appears later than 10 days after application may be a sign of contact sensitisation.

TRUE Test 36 should only be applied to skin that is:

• free of acne
• free of scars
• free of dermatitis
• in a condition, which cannot interfere with the test results. You should check with your doctor if you are not sure.

Moisture around the test must be avoided. There-fore, when bathing or showering, you must be care-ful not to get the test panel or surrounding area wet. If the test panel does become wet it may loosen, allowing the test substances to be washed away.

Avoid any activity such as sunbathing or exercising, which may cause the patches to loosen.

Butylated hydroxyanisole (BHA) (E320) and Butyl-ated hydroxytoluene (BHT)(E312) are present in allergen patch no. 7 Colophony (panel 1) for stability purposes. BHA and BHT may cause local skin reac-tions (e.g. contact dermatitis), so a false positive reaction for Colophony may occur.

The following information is intended for medical or healthcare professionals only:

An identification template is provided with each package of TRUE Test 36 for quick and easy identification of any allergen causing 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 only, no or very little infiltration

+ weak (nonvesicular) positive reaction: ery-thema, mild infiltration, possible papules

++ strong (vesicular) positive reaction: erythema, infiltration, papules, vesicles

+++ extreme positive reaction: intense erythema, infiltrate, 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 homo-geneous erythema without infiltration are usually signs of irritation and do not indicate allergy.

What is important in evaluating a positive test response is not the number of plusses assigned to the test response, but determining whether the response is a truly positive reaction (caused by allergy) or a non-specific irritant reaction.

3 4 A TRUE TEST ^® 36

Plaster for provocation test

TRUE Test 36 consists of 3 strips of surgical tape, each strip contains 12 patches. 35 of the patches are coated with a film containing a specific allergen or a mix of allergens. One patch (patch no. 9) is a blank patch

Package leaflet: Information for the user

Panel 1

1 Nickel sulphate 200 162 2 Wool alcohols 1000 810 3 Neomycin sulphate 600 486 4 Potassium dichromate 54 44 5 Caine mix^a) 630 510 6 Fragrance mix^b) 430 348 7 Colophony 1200 972 8 Paraben mix^c) 1000 810 9 Blank patch - - 10 Balsam of Peru 800 648 11 Ethylenediamine dihydrochloride 50 41 12 Cobalt chloride 20 16

Panel 2

13 p-tert Butylphenol 45 36 formaldehyde resin

14 Epoxy resin 50 41 15 Carba mix^d) 250 203 16 Black rubber mix^e) 75 61 17 Cl+Me-Isothiazolinone 4 3 18 Quaternium-15 100 81 19 Methyldibromoglutaronitrile 5.0 4.1 20 p-Phenylenediamine 80 65 21 Formaldehyde^f) 180 146 22 Mercapto mix^g) 75 61 23 Thiomersal 7 6 24 Thiuram mix^h) 27 22

microgram/ microgram/ cm² patch

microgram/ mg/ cm² pacth Children

TRUE Test is not recommended for use in children, since its safety and efficacy have not been deter-mined in these patients.

Other medicines and TRUE Test 36

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription, before TRUE Test 36 is applied. Remember that the skin specialist may not be aware of your other medicines.

Since steroids may suppress a positive test reaction, use of topical steroids on the test site or oral steroids equivalent to 20 mg prednisolone or more daily should be discontinued for at least two weeks prior to testing.

Pregnancy, breast-feeding and fertility

Pregnant women should not use TRUE Test 36. It is important to tell your doctor if you are pregnant or think you might be pregnant.

You should not breastfeed your baby while using TRUE Test 36

Driving and using machines

TRUE Test 36 is unlikely to affect your ability to drive or use machines. Talk to your doctor about this if you have any concerns.

3. How to use TRUE Test 36

TRUE Test 36 is applied by your doctor.

1. 1. Peel open the pack-age and remove the TRUE Test 36 panel.
2. 2. Remove the pro-tective plastic cover-ing the surface of the panel. Be careful not to touch the test sub-stances. A desiccant is included in the pack-age for panel 2 for sta-bility purposes.

B 6 7 8

1. 3. Position the test on the upper back of the patient. However, the outer part of the upper arms is also accept-able. From the centre of the panel, smooth out-ward toward the edges,

makes adequate contact

wo panels are best positioned

e backbone, a few centimetres

rd panel is placed next to one of the

1. 4. The two notches on the panels (top left and in the lower edge) are indicated with a medi-cal marking pen.

You should wear the test strips for 48 hours without removing them. You should be careful not to get the test area wet (water, sweat).

If the plaster is removed or detaches too early, it is possible that you could miss positive reactions to allergens that you are actually allergic to. Please contact your doctor if the plaster is removed or detaches before 48 hours.

After 48 hours you or your doctor may remove the panels.

When should the results be read?

Your doctor will read the test result half an hour after removal of the test and again 1-2 days after removal of the test, when any allergic reactions are fully developed and possible irritant reactions have faded. A few allergens sometimes cause reactions which may not appear until 4-5 days after removal of the test. Please inform your doctor if this happens.

What is the doctor looking for?

The doctor will carefully examine the test area for signs of an allergic reaction. This reaction usually con-sists of a rash with swelling, redness and tiny blisters. Redness alone, however, does not necessarily mean that it is an allergic reaction. If you are allergic, your doctor will provide you with the following information:

• Where in your everyday surroundings, you are likely to come into contact with the offending substances.

  • How best to avoid these substances. Your doctor may suggest alternatives to the items you should avoid.

You should check with your doctor or pharmacist if you are not sure.

You should contact a doctor if you experience severe discomfort at the test site.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common side effects (may affect more than 1 in 10 people):

• Irritation caused by the surgical tape adhesive may occur, but usually disappears rapidly.
• Burning sensation.
• Long-lasting test reactions. A positive test reac-tion usually disappears within 1-2 weeks, whereas a long-lasting test reaction may persist for weeks or months.

Common side effects (may affect up to 1 in 10 people):

• Test reactions may leave a temporary area of either pale or darker coloured skin.
• Redness of the skin caused by irritation or inflam-mation (erythema)

Uncommon side effect (may affect up to 1 in 100 people):

• A flare-up of your dermatitis.

Rare side effect (may affect up to 1 in 10,000 people):

• Sensitisation to a substance on the test panel may occur with patch testing.

Not known (frequency cannot be estimated from the available data)

• Anaphylactic reaction (systemic reaction, possibly with a life-threatening drop of blood pressure).
• Hypersensitivity (allergic reaction).

In extremely rare cases and only in relation to cer-tain substances, anaphylactic reactions (systemic reaction, possibly with a life-threatening drop of blood pressure) have occurred. The allergy depart-ments are for other reasons prepared to treat such incidences. Anaphylactic type reactions in relation to application of TRUE tests are not documented.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TRUE Test 36

Store in a refrigerator (2°C – 8°C).

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packing after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What TRUE Test 36 contains

In addition to the active substances indicated on the first page, the test contains the following excipients: Tape of polyester fibres plus binder (ethylene vinyl acetate copolymer) with acrylic adhesive, polyester patches, povidone 90, hydroxypropylcellulose, methylcellulose, ß-cyclodextrin, sodium carbonate, sodium bicarbonate butylhydroxyanisole and butylhydroxytoluene.

What TRUE TEST 36 looks like and contents of the pack

Each panel is coated with a protective foil consist-ing of silicone-coated polyethylene and packed in sealed pouches of laminated foil.

The Panel 2 foil pouch also contains a desiccant to keep the allergens fresh during storage. Contents of the pack: 10 test (1 test = one Panel 1, one Panel 2 and one panel 3).

Marketing Authorisation Holder and Manufacturer SmartPractice Denmark ApS

Herredsvejen 2, 3400 Hillerød, Denmark info@smartpractice.dk

Distributed by:

Diagenics Limited

Ground Floor Office 2, Mount House Block C, Bond Avenue, Bletchley, Milton Keynes, MK1 1SF This leaflet was last revised in April 2023. 52-0702-00/3 All positive reactions should be carefully evaluated, considering clinical history and symptoms of the individual patient, particularly in case of positive reactions to specific allergens with lower relevant sensitisation rates (i.e. gold sodium thiosulphate). Some of the allergens (neomycin sulphate,p-phenylenediamine, wool alcohols, caine mix, gold sodium thiosulfate, parthenolide, disperse blue 106, bacitracin, imidazolidinyl urea, diazolidinyl urea, budesonide, hydrocortisone-17-butyrate and tixocortol-21-pivalate) sometimes cause reactions, which may not appear until 4-5 days after the appli-cation. Patients should be instructed to report this. If appropriate, an additional office visit with a late reading at day 5-7 will verify a late reaction.

Contraindications

Severe or generalized dermatitis. The testing should be delayed until the acute course of contact dermatitis is over. Known hypersensitivity towards other excipients contained in the test besides the active substances Special warnings and precautions for use

Sensitisation to a substance on the test panel only seldom occurs. A test reaction that appears on day 10 or later may be a sign of contact sensitisation. Excited skin syndrome (angry back) is a state of hyperreactivity induced by dermatitis on other parts of the body or by a strong positive skin test reaction. Therefore, test results should be evaluated carefully in patients with multiple, positive, concomitant patch test results. To determine which reactions are false positive, retesting at a later date may be necessary. The use of TRUE Test 36 in patients with known his-tory of anaphylactoid reactions should be carefully evaluated before application.

Excessive sweating and sun exposure of the test site is to be avoided. Suntan may decrease patch test reactivity and cause false negative tests. Avoid applying the test on skin with acne, scars, der-matitis or any other condition that may interfere with test results

If a severe patch test reaction develops, the patient may be treated with a topical corticosteroid or, in rare cases, with a systemic corticosteroid. Butylated hydroxyanisole (BHA) (E320) and Butyl-ated hydroxytoluene (BHT)(E312) are present as antioxidants in allergen patch no. 7 Colophony (panel 1). BHA and BHT may cause local skin reac-tions (e.g. contact dermatitis), so a false positive reaction for Colophony may occur.