Patient leaflet - Colourstart Test 65 mcg cutaneous patch

1. What Colourstart is and what it is used for

Colourstart is a ready-to-use patch test for finding out if you might

inflamed and may have tiny blisters. If you have not shown an be allergic to one of the ingredients (PPD) in hair colorants. PPD is

allergic response, the skin under this patch will not react. It will look present in more than two out of three hair colorants. PPD is known to

normal and similar to the skin under the control patch (marked A-).

cause allergic reactions, which may be severe, in some individuals.

If your hair colorant recommends that you carry out an allergy alert

If a substance to which you are allergic (an allergen) comes into contact

test prior to application, Colourstart can be used instead of this test with your skin it causes a reaction often called contact dermatitis.

to test for allergy to PPD.

The test consists of surgical tape with two patches. One of the

Colourstart works by showing if you are likely to be allergic to PPD patches (marked A+) is the active patch containing PPD. The other

only and will not detect if you might be allergic to other ingredients in patch (marked A-) is the control patch with no PPD present.

hair colorants.

Colourstart works by showing if you are allergic to the PPD patch

The absence of a reaction following use of Colourstart does not

(marked A+). If you are likely to be allergic to PPD then the skin

guarantee a safe hair colour treatment, but by using this product under the patch (marked A+) will react to it becoming red and

correctly, you can minimise the risk of reaction to hair colorant.

2. What you need to know before you use Colours

tart

Do not use Colourstart if you

Warnings and precautions: sensitisation

suspect or know that you are allergic to PPD or any of the other
In rare instances, you may become allergic to the PPD present ingredients of this medicine (See section 6)
on the Colourstart patch. This is also a risk with exposure to hair
if you have active dermatitis on your skin (e.g. redness,
colorants containing PPD. Any reaction which occurs at the site of swelling, itching)
where the patch was applied, approximately 10 days later, may be
have previously experienced an allergy to hair colorant
if you are pregnant or breast-feeding
if you are taking oral or topical steroids and other
immunosuppressant medicines
a sign of contact sensitisation. If this happens talk to your doctor or pharmacist and DO NOT use hair colorants if this happens.
Talk to your doctor or pharmacist if you require further advice regarding use of this product or in deciding if it is suitable for you.

See section “Taking other medicines and Colourstart” below.

Take special care with Colourstart

A temporary black henna tattoo may increase your risk of

having an allergic reaction when you colour your hair.

DO NOT use Colourstart if you have a temporary black

henna tattoo

DO NOT use Colourstart if you have had any reaction to a

if you go out in the sun regularly, as you should avoid exposing the area where the patch is applied to the sun. This is particularly important during the summer.
avoid getting the patch excessively wet as this may cause the patch to loosen and stop working properly. Take care therefore when bathing, showering or during periods of exercise where you temporary black henna tattoo in the past.
may sweat.

DO NOT perform the “Allergy Alert Test” as instructed on hair

colorants in addition to using this medicine. This is because repeated

exposure of the skin to PPD whether in applying hair colorant,

performing the “Allergy Alert Test” or in using Colourstart, may cause

sensitisation (development of allergy) in some individuals. For this

reason, Colourstart Test Patch should not be used more than once

if you are using the same hair colour product, but may be repeated

if you switch to a new hair colour product. (See “Warnings and

Taking other medicines and Colourstart

Do not use Colourstart if you are taking oral or topical steroids (such as prednisolone, betamethasone, dexamethasone, fludrocortisone, fluticasone, hydrocortisone or immunosuppressant medicines (such as tacrolimus, cyclosporine, mycophenolate, azathioprine, sirolimus)

as they may suppress a positive reaction. If you are unsure if any medicines you may be taking will interfere with Colourstart, you should speak to your pharmacist.

precautions: sensitisation”).

Pregnancy, breast-feeding and fertility

Pregnant women should not use Colourstart.

Colourstart is not recommended for adolescents and children under

If you are pregnant or think you might be pregnant or are planning to

16 years of age. Hair colorants are not intended for use by children

have a baby ask your doctor or pharmacist for advice before taking under 16 years of age.

this medicine.

You should not use Colourstart if you are breast-feeding your baby.

Driving and using machines

There are no known effects of Colourstart on driving or

using machinery.

14.04.2023 08.14

29.05.2026 09.38

3. How to use Colourstart

Always apply the self-adhesive patch at least 5 days before any colouring process. This is because PPD sensitivity sometimes causes reactions which may not appear until 4 to 5 days after

application.

Always use this medicine exactly as described in this leaflet.

Colourstart is not recommened for adolescents and children under

16 years of age.

Adults and adolescents aged 16 years and over:

The instructions and diagrams below relate to the use of the patch

on the upper arm.

Select a clean, dry, intact area of skin to apply the patch. The

patch should be applied only to healthy skin that is free of acne,

scars, dermatitis or any other condition that may interfere with

the test results. Avoid placing the patch on areas of the skin

where creams or emollients have been applied as these may

affect how the patch sticks to the skin.

Directions

1. Wash your hands before applying the patch.
2.
Peel open the foil pouch and remove the patch.
Remove the tab marked “1” from the surface of the patch whilst
taking care not to touch the patches (see Figure 1).

Figure 2 Figure 1

3.
Whilst holding the patch
at the edge with finger tips
place it on the upper arm
(above the elbow but below
the shoulder) where you will
be able to see the
test results.
The patch should be
Figure 3
smoothed from the centre
to the outer edges (see Figure 2).
The second tab, marked with a “2” should then be removed (see
Figure 3) and the patch smoothed from the centre to the outer
edges (see Figure 2).
Once the patch is in place you will see one patch marked “A+”,
which is the active patch containing PPD and one clear patch
marked “A-”, which is the control patch with no PPD allergen.

You should wear the patch for at least 48 hours without removing it.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although

not everybody gets them.

The side effects could include:

a flare-up of your dermatitis, if the test is used during an active
phase of your skin disease.
sensitisation to PPD on the test patch. A test reaction that occurs
at the site where the patch was applied, approximately 10 days
later, may be a sign of contact sensitisation (see section 2 above).
If this happens talk to your doctor or pharmacist and DO NOT use
hair colorants.
a positive test reaction usually disappears within 1-2 weeks.
On rare occasions, a positive test reaction may last for weeks
or months. Such reactions will leave a temporary area of pale
coloured skin (hypopigmentation) or darker coloured skin
(hyperpigmentation).

5. How to store Colourstart

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

Colourstart should be stored below 25°C.

Do not use Colourstart after the expiry date which is stated on the

foil pouch. The expiry date refers to the last day of

that month.

6. Contents of the pack and other information

What Colourstart contains

The substance in the ‘active’ (marked A+) patch is:
p-Phenylenediamine (PPD) 65 micrograms.

The patch marked (A-) is the control, which does not contain PPD

The other ingredients in the patches are: ethanol, povidine 90

What Colourstart looks like and contents of the pack

Colourstart consists of surgical tape with two patches. One of the

patches (marked A+) is the active patch containing PPD. The other

patch (marked A-) is the control patch with no PPD.

Colourstart is available as a single use self-adhesive plaster inside a

foil pouch.

The foil pouch also contains a special type of paper or film

The foil pouch also contains a desiccant to keep the patch

(desiccant) to keep the patch fresh during storage.

fresh during storage.

May 2026.

This leaflet was last revised in March 2023.

hexagon logo are registered trademarks belonging to

Trichocare Diagnostics Ltd.

If you experience any symptoms of discomfort or there is a noticeable difference in how your skin looks or feels in this

48 hour period, remove the patch and wash the area gently with water as it may be a positive result. DO NOT apply hair colorant.

Talk to your pharmacist or doctor if you are at all unsure.

After 48 hours you may remove the patch.

Identifying the results

Wait 20 to 30 minutes after removing the patch and then examine your arm to look for any signs of an allergic “positive” test reaction.

If the test is positive, indicating potential allergy to hair colorant, the area under the patch marked A+ will look different to that marked A-.

A positive result is usually seen as a rash, redness and tiny blisters. It may also itch and or feel warm. Note that the redness may not be evenly spread across the area.

If you see a reaction to Colourstart, DO NOT apply hair colorant.

You may suffer a worse reaction. You should seek medical advice from your doctor.

If a severe patch test reaction develops which is seen as intense redness with large fluid filled blisters, talk to your doctor immediately. DO NOT apply hair colorant.

If no positive test result is seen continue to look at the area for a further

48 to 72 hours to see if there is a change in the skin. There should be no visible differences in the two patches marked A+ and A-.

It is important to continue to look at the area for at least 5 days after initial application of the patch. This is because PPD sensitivity sometimes causes reactions which may not appear until 4 to 5 days after the application. If this occurs seek advice from your doctor.

Colourstart works by showing if you are likely to be allergic to PPD only and will not detect if you might be allergic to other ingredients in hair colorants. The absence of a reaction following use of Colourstart does not guarantee a safe hair colour treatment, but by following these safety instructions, you can minimise risk.

If you use more Colourstart than you should

This is not possible if you use Colourstart only as directed as it is a single use patch.

If you put on more than one patch, or if anyone else has put a patch on their skin accidentally, remove it as soon as you can and wash the area gently with water.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

irritation and or itching caused by the surgical tape glue may occur, but usually disappears rapidly.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: 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.

Do not use this medicine if you notice that the foil pouch is open or damaged.

The used patch should be folded, sticky sides together, put back in the empty pouch and disposed of carefully.

Always dispose of used Colourstart patches sensibly, away from the reach of children and animals.

Marketing Authorisation Holder and Manufacturer

Trichocare Diagnostics Ltd

Manufacturer

Worlds End Studios

Smartpractice Denmark ApS

132-134 Lots Road

DK-3400 Hillerod

London SW10 0RJ

Denmark

United Kingdom

52-4008-00/6