use tolerance of Burnol Plus Antiseptic Cream

• Research type

  Research Study

• Full title

  Single centre evaluation of the in use tolerance of Burnol Plus Cream on broken skin in healthy adult subjects

• IRAS ID

  56750

• Contact name

  Alex Thompson

• Eudract number

  2010-019800-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Burnol Plus Antiseptic Cream is a topical antiseptic product, intended for minor cuts, wounds, sores, insect bites, rashes and abrasions, containing Aminacrine and Cetrimide which are antiseptic agents.This single centre, open label study will assess the in use tolerance of Burnol Plus Antiseptic Cream (assessed by the scoring of redness, oedema, dryness and roughness / scaling over a 24 hour period) of topical application of Burnol Plus Antiseptic Cream on artificially broken skin in healthy volunteer subjects. The test methodology (tape stripping to induce artificially broken skin) is a recognised technique for the assessment of the tolerance of topical products. A previous in use tolerance study for Dettol Wound Wash spray used the same technique using 'full damage' and 'half damage' test sites.An artificially induced skin damage model (inner forearm) with test product application in line with on-pack instructions is considered to approximate likely in-use product usage conditions and thus provides an appropriate assessment of in-use tolerance.The healthy volunteers are not expected to derive any benefit from participating in the study. Although Reckitt Benckiser has no clinical or non clinical data on the known actives, Burnol Plus Antiseptic Cream has been a marketed product in East Asia for 65 years and there have been no pharmacovigilance reports of the product, therefore the potential risks to healthy volunteers are considered to be low. This study will be conducted in accordance with the Declaration of Helsinki (South Africa, 1996), as referenced in EU Directive 2001/20/EC. It will comply with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and applicable regulatory requirements.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/15

• Date of REC Opinion

  23 Jun 2010

• REC opinion

  Further Information Favourable Opinion