Colourstart® Test 73 mcg Cutaneous Patch. TDL-CS-001 Version 1.0

• Research type

  Research Study

• Full title

  An open label, intra-subject, controlled multi-centre study to assess the concordance (specificity and sensitivity) between Colourstart® Test 73 mcg Cutaneous Patch and Finn Chamber in the detection of para-Phenylenediamine (PPD) allergy in subjects with known or clinically suspected allergy and those with no known allergy.

• IRAS ID

  146280

• Contact name

  John English

• Contact email

  john.english@nhs.net

• Eudract number

  2014-001218-24

• Research summary

  For many years allergic contact dermatitis has been associated with the use of hair dyes. A key allergen used in hair dye is para-Phenylenediamine (PPD). Although the large majority of users do not experience adverse skin reactions to such products, allergic reactions are not uncommon, with a minority exhibiting features of a severe response. Current advice is that the consumer or hairdresser is expected (by the manufacturer) to limit the chance of allergy by conducting a ‘sensitivity test’ involving the direct application of hair dye directly to the skin, to alert a possible allergy. These tests are unpopular and do not work to an acceptable level of specificity (correct identification of negatives) or sensitivity (correct identification of positives).
  Colourstart® Test 73 mcg Cutaneous Patch (Colourstart) is a product that detects allergy to PPD.
  This study is designed to directly compare Colourstart to a procedure used by dermatologists to diagnose allergy to hair dye. It will focus on the ability of Colourstart to identify those subjects who are Finn Chamber negative from those who are Finn Chamber positive and therefore at most potential risk from exposure to hair dye containing PPD.
  This is a 2 week, multi-centre study. Colourstart will be applied once for 48 hours at the same time as applying Finn Chamber PPD in subjects with known or clinically suspected allergy to PPD and no known allergy to PPD. The study will be conducted on an outpatient basis from UK dermatology clinics. Approximately 240 subjects will be enrolled.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  14/EM/0209

• Date of REC Opinion

  3 Jun 2014

• REC opinion

  Further Information Favourable Opinion