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TRUE TEST 24 PLASTER FOR PROVOCATION TEST

Active substance(s): ALPHA-AMYLCINNAMALDEHYDE / BENZOCAINE / BENZYL PARAHYDROXYBENZOATE / BUTYL PARAHYDROXYBENZOATE / CHLORQUINALDOL / CINNAMALDEHYDE / CINNAMYL ALCOHOL / CLIOQUINOL / COBALT DICHLORIDE / COLOPHONY / DER 331 EPOXY RESIN / DIBUCAINE HYDROCHLORIDE / DIPENTAMETHYLENETHIURAM

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a) Five parts of benzocaine, one part of cinchocaine hydrochloride
and one part of tetracaine hydrochloride.
b) Five parts of geraniol and oak moss, four parts of hydroxycitronellal and cinnamyl alcohol, two parts of cinnamaldehyde and
eugenol and one part of isoeugenol and α-amylcinnamaldehyde.
c) Equal parts of methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate and benzyl parahydroxybenzoate.
d) Equal parts of clioquinol and chlorquinaldol.
e) Equal parts of diphenylguanidine, zincdiethyldithiocarbamate and
zincdibutyldithiocarbamate.
f) Two parts of N-isopropanol-N’-phenyl paraphenylenediamine, five
parts of N-cyclohexyl-N’-phenyl paraphenylenediamine and five
parts of N, N’-diphenyl paraphenylenediamine.
g) Contains N-hydroxymethyl succinimide.
h) Equal parts of morpholinylmercaptobenzothiazole, N-cyclohexylbenzothiazylsulphenamide and dibenzothiazyl disulphide.
i) Equal parts of disulfiram, dipentamethylenethiuram disulphide,
tetramethylthiuram disulphide and tetramethylthiuram monosulphide.

®

TRUETEST 24
Plaster for provocation test
TRUE Test 24 consists of 2 strips of surgical tape,
each strip contains 12 patches. Each patch is coated
with a film containing a specific allergen or a mix
of allergens.

Panel 1
microgram/mg/
cm2
1 Nickel sulphate
200
2 Wool alcohols
1000
3 Neomycin sulphate
600
4 Potassium dichromate
54
5 Caine mixa)
630
6 Fragrance mixb)
430
7 Colophony
1200
8 Paraben mixc)
1000
9 Quinoline mixd)
190
10 Balsam of Peru
800
11 Ethylenediamine dihydrochloride
50
12 Cobalt chloride
20

pacth
162
810
486
44
510
348
972
810
154
648
41
16

Panel 2
13
14
15
16
17
18
19
20
21
22
23
24

p-tert Butylphenol
formaldehyde resin
Epoxy resin
Carba mixe)
Black rubber mix (PPD mix)f)
Cl+Me-Isothiazolinone
Quaternium-15
Mercaptobenzothiazole
p-Phenylenediamine
Formaldehydeg)
Mercapto mixh)
Thiomersal
Thiuram mixi)

45

36

50
250
75
4
100
75
80
180
75
7
27

41
203
61
3
81
61
65
146
61
6
22

Read all of this leaflet carefully before you start
using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor,
pharmacist or nurse.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.What TRUE Test 24 is and what it is used for
2.What you need to know before you use TRUE Test
24
3.How to use TRUE Test 24
4.Possible side effects
5.How to store TRUE Test 24
6.Contents of the pack and other information

1.What TRUE Test 24 is and what it is used for
TRUE Test 24 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 24 is a ready-to-use patch test for determining the cause of allergic contact dermatitis.
The test consists of 2 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. TRUE Test 24 contains
24 of the most common allergens/allergen mixes.
TRUE Test 24 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,
rubber gloves, industrial chemicals, etc. The substances in TRUE Test 24 are well-known allergens.
If you are allergic to the substance in a particular
TRUE Test 24 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.

• 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 anaphylactioid reactions.
The use of TRUE Test 24 should be considered
carefully.
• If you have strong contact allergy. TRUE Test 24
should be used with caution since it may lead to
transient flare of previous dermatitis sites.
Talk to your doctor before using TRUE Test 24 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 24. A test reaction that appears later
than 7 days after application may be a sign of contact sensitisation.
TRUE Test 24 should be applied only to skin that is:
• free of acne
• free of scars
• free of dermatitis
• in a condition, which can not interfere with the test
results. You should check with your doctor if you
are not sure.
Moisture around the test must be avoided. Therefore, when bathing or showering, you must be careful 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.

2.What you need to know before you use TRUE
Test 24

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

Do not use TRUE Test 24:
• If you suffer from acute contact dermatitis. The
testing should be delayed until the acute course
of contact dermatitis is over.

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

Warnings and precautions
• You should avoid exposing the test area to the
sun.
• avoid sweating profusely while wearing the patch
test strips.
• if you are taking 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.

Other medicines and TRUE Test 24
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 24 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

3

4



Package leaflet: Information for the user

The following information is intended for medical or healthcare professionals only:
An identification template is provided with each
package of TRUE Test 24 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: erythema, mild infiltration, possible papules

++

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

+++ extreme positive reaction: bullous reaction
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 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.
A

Contraindications
Acute contact dermatitis. The testing should be
delayed until the acute course of contact dermatitis
is over.



Neomycin sulphate and p-phenylenediamine sometimes cause reactions which may not occur until 45 days after the application of the test strips. The
patient should be instructed to report this. If appropriate, an additional office visit will verify a late reaction.

steroids equivalent to 10 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 24. 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 24.

Special warnings and precautions for use
The substances on the test panel seldom lead to
sensitisation. A test reaction that appears later than
7 days after application of the test may be a sign of
contact sensitisation.

Driving and using machines
TRUE Test 24 is unlikely to affect your ability to drive
or use machines. Talk to your doctor about this if
you have any concerns.

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.

3.How to use TRUE Test 24
1. Peel open the package and remove the
TRUE Test 24 panel.

The doctor should avoid applying the test on skin
with acne, scars, dermatitis or any other condition
that may interfere with test results.

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

If a severe patch test reaction develops, the patient
may be treated with a topical corticosteroid or, in
rare cases, with a systemic corticosteroid.

3. Position the test on
the upper back of
the patient. However, the outer part
of the upper arms
is also acceptable.
From the centre of
the panel, smooth
outward toward the edges, making sure each allergen makes adequate contact with the skin. The two
panels are best positioned on each side of the
backbone with a distance of a few centimetres.

B

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

5

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

4. Possible side effects

6. Contents of the pack and other information

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

What TRUE Test 24 contains
In addition to the active substances indicated on
the first page, the test contains the following excipients:
Tape of cellulose acetate with acrylic adhesive,
polyester patches, povidone 90, hydroxypropylcellulose, methylcellulose, -cyclodextrin, sodium carbonate, sodium bicarbonate butylhydroxyanisole and
butylhydroxytoluene.

Very common side effects (affects more than 1 in 10
people):
• Irritation caused by the surgical tape adhesive
may occur, but usually disappears rapidly.
• Long-lasting test reactions. A positive test reaction usually disappears within 1-2 weeks, whereas a long-lasting test reaction may persist for
weeks or months.

What TRUE Test 24 looks like and contents of the
pack

Common side effects (affects more than 1 in 100
people but less than 10 people):
• Test reactions may leave a temporary area of
either pale or darker coloured skin.

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

Uncommon side effect (affects more than 1 in 1,000
people but less than 1 in 100 people):
• A flare-up of your dermatitis.

The Panel 2 foil pouch also contains a special type
of paper (desiccant) to keep the allergens fresh during storage.

Rare side effect (affects more than 1 in 10,000 but
less than 1 in 1,000 people):
• Sensitisation to a substance on the test panel
may occur with patch testing.

Contents of the pack: 1 or 10 test (1 test = one Panel
1 and one Panel 2)

Reporting of side effects
If you get any side effects, talk to your doctor. 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.

SMARTPRACTICE DENMARK ApS
Herredsvejen 2
3400 Hillerød
Denmark
info@smartpractice.dk

By reporting side effects you can help provide more
information on the safety of this medicine.

Marketing Authorisation Holder and Manufacturer

Distributed by:
Diagenics Ltd
South House 3, Bond Avenue, Bletchley
Milton Keynes MK1 1SW, United Kingdom

5. How to store TRUE Test 24
Store in a refrigerator (2°C – 8°C).
Keep this medicin out of the sight and reach of children.

You should contact a doctor, if you experience
severe discomfort at the test site. Your doctor can
decide to remove the test.

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

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.

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

6

7

This leaflet was last revised in 09/2014
52-XXXX-DCP UK

8

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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