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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/
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

mg/
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.
TRUE Test 24 is for use in adults.
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.

(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 anaphylactioid reactions.
The use of TRUE Test 24 should be considered
carefully.
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 10 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.

$

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: 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.

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 severe or generalized dermatitis. The testing should be delayed until the acute
course of dermatitis is over.
• If you know you are allergic to any of the other
excipients in TRUE Test 24 (listed in section 6).

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

Warnings and precautions
• You should avoid exposing the test area to the
sun. Sun tan may cause that you 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

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

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

• 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.

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.

$

Neomycin sulphate and p-phenylenediamine sometimes cause reactions which may not appear until
4-5 days after the application of the test strips. The
patient 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.

scription, 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 steroids
equivalent to 20 mg prednisolone or more daily should
be discontinued for at least two weeks prior to testing.

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

B

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

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.
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.
3. How to use TRUE Test 24
TRUE Test 24 is applied by your doctor.
1. Peel open the package and remove the
TRUE Test 24 panel.

The use of TRUE Test 24 in patients with known
history of anaphylactoid reactions should be carefully evaluated before application.
Excessive sweating and sun exposure of the test
site is to be avoided. Sun tan may decrease patch
test reactivity and cause false negative tests.

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.

2. R
 emove the protective plastic covering the surface of
the panel. Be careful not to touch the
test substances.
A desiccant paper
is included in the
package for panel 2 for stability purposes.
3. P
 osition 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
5

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).
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.
You should contact a doctor, if you experience
severe discomfort at the test site. Your doctor can
decide to remove the test.
6

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.

5. How to store TRUE Test 24

Please contact your doctor, if the plaster is removed
or detaches before 48 hours.

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

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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.
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.
Uncommon side effect (affects more than 1 in 1,000
people but less than 1 in 100 people):
• A flare-up of your dermatitis.
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.
In extremely rare cases and only in relation to certain substances, anaphylactic reactions (systemic
reaction, possibly with a life-threatening drop of
blood pressure) have occurred. The allergy departments 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. 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.
By reporting side effects you can help provide more
information on the safety of this medicine.
7

Store in a refrigerator (2°C – 8°C).

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. Contents of the pack and other information
What TRUE Test 24 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 acetate
copolymer) with acrylic adhesive polyester patches,
povidone 90, hydroxypropylcellulose, methylcellulose, ß-cyclodextrin, sodium carbonate, sodium
bicarbonate butylhydroxyanisole and butylhydroxytoluene.
What TRUE Test 24 looks like and contents of the pack.
Each panel is coated with a protective foil consisting 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
SMARTPRACTICE DENMARK ApS
Herredsvejen 2
3400 Hillerød
Denmark
info@smartpractice.dk
Distributed by:
Diagenics Ltd
South House 3, Bond Avenue, Bletchley
Milton Keynes MK1 1SW, United Kingdom
This leaflet was last revised in May 2017
52-0181-00/1

8

Expand Transcript

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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