Colourstart Test 65 Mcg Cutaneous Patch
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colourstart Test 65 mcg Cutaneous Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Colourstart is a self-adhesive plaster consisting of a piece of surgical tape with two polyester patches, one with P-Phenylenediamine (PPD) ('active patch') and one control patch ('negative patch').
Active patch (A+)
Each patch contains 65 micrograms PPD in a patch size of 0.9 cm x 0.9 cm (0.81 cm2), which is equivalent to 80 micrograms/cm2.
Negative patch (A-)
Each patch contains 0 micrograms PPD in a patch size of 0.9 cm x 0.9 cm (0.81 cm2), which is equivalent to 0 micrograms/cm2.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Plaster for provocation test (cutaneous patch): self-adhesive plaster for cutaneous use.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Colourstart is indicated for the diagnosis of allergic contact dermatitis to PPD (para-phenylenediamine).
4.2 Posology and method of administration
A dosage level for PPD has been established that is high enough to evoke a reaction even in weakly sensitised patients, yet low enough to minimise the risk of irritant reaction.
The test is best applied on the upper part of the back, about 5cm from the midline, but the outer part of the upper arm is also acceptable.
1) Peel open the package and remove the plaster.
2) Remove the protective tabs marked “1” from the surface of the plaster whilst taking care not to touch the patches.
3) Whilst holding the plaster at the edge with finger tips, place it on the back or upper arm (above the elbow but below the shoulder) where the test result will be easily seen. The plaster should be smoothed from the centre to the outer edges.
4) The second set of protective tabs marked “2” should then be removed.
The test should be applied to healthy skin that is free from acne, scars, dermatitis or any other condition that might interfere with interpretation of results (see Precautions).
The patient should wear Colourstart for a minimum of 48 hours without removing it and being careful not to get the test area wet.
Following this period, the test is removed, either by the physician or the patient. Interpretation
The reaction should be read at 72-96 hours. If a reading at 48 hours is considered, this evaluation must be completed with a reading at 72-96 hours, when allergic reactions are fully developed and mild irritant reactions have faded.
P-phenylenediamine, however, sometimes causes reactions which may not appear until 4-5 days after the application. Patients should be instructed to report this. If appropriate, an additional consultation will verify a late reaction.
The interpretation method recommended by the International Contact Dermatitis Research Group and the North American Contact Dermatitis Group is:
? doubtful reaction, faint macular erythema only
+ weak (nonvesicular) positive reaction: erythema, infiltration,
possible papules
++ strong (vesicular) positive reaction: erythema, infiltration, papules,
vesicles
+++ extreme reaction
- negative reaction
IR irritant reaction of different types
NT not tested
Note:
• Patients showing a negative reaction may still be sensitised to other substances not included in this test. 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 homogenous 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.
Paediatric use
The safety and effectiveness of Colourstart in children has not been established.
4.3 Contraindications
Extensive ongoing active dermatitis.
4.4 Special warnings and precautions for use
Excited skin syndrome (angry back) is a state of hyper-reactivity induced by dermatitis on other parts of the body or by a strong positive skin-test reaction. To determine which reactions are false positive, retesting at a later date may be necessary.
Sensitisation to the substance on the test panel may occur with patch testing. A test reaction that appears later than 10 days after application of the test may be a sign of contact sensitisation.
Excessive sweating and sun exposure of the test site is to be avoided.
The test should be applied only to healthy skin that is free of 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.
4.5 Interaction with other medicinal products and other forms of interaction
Since steroids may suppress a positive test reaction, use of topical steroids on the test site or oral steroids (equivalent to 10 mg prednisolone) should be discontinued for at least two weeks prior to testing.
4.6 Fertility, pregnancy and lactation
Reproduction studies have not been conducted with Colourstart. The test is therefore not recommended to be applied to the skin of pregnant women. No studies have been performed to evaluate absorption of the PPD in Colourstart in nursing mothers.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Local
A positive test reaction usually disappears within 1 to 2 weeks. On rare occasions, test reactions may persist for a month, leaving an area of transient hypopigmentation.
Irritation caused by the surgical tape adhesive may occur, but usually disappears rapidly.
General
Sensitisation (see Special Warnings 4.4)
A flare-up of dermatitis may be observed when testing during an active phase of dermatitis.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Patch testing is a well established procedure which leads to a type IV reaction if sensitivity is present.
Although the response can appear as early as six hours, it is believed that the most accurate interpretation may be made between 72 and 96 hours after application since "irritant" reactions will have faded by then.
5.2 Pharmacokinetic properties
There is no information of relevance to the prescriber.
5.3 Preclinical safety data
There is no information of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Solvent
Vehicle
Ethanol 99.5%
Polyvidone 90
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
18 months.
6.4 Special precautions for storage
Store below 25°C. The expiry date is stated on the package.
6.5 Nature and contents of container
Each self-adhesive plaster consists of a piece of surgical tape with two polyester patches (active and negative), covered by protective sheets of silicone-treated polyethylene marked “1” and “2”and then packed in a sachet of packaging laminate.
The Colourstart sachet also contains a desiccant paper.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Trichocare Diagnostics Ltd,
Berry End Farm House Berry End Eversholt
Bedfordshire MK17 9EB United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 33784/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/12/2012
10 DATE OF REVISION OF THE TEXT
11/03/2015