Protocol No FPP4-DE-401 Penciclovir 1% Cream Efficacy Study

• Research type

  Research Study

• Full title

  A randomised, double-blind, vehicle controlled, single centre, parallel group, comparative study of the efficacy of penciclovir 10mg/g (1%) cream in preventing the appearance of classical lesions in recurrent cold sore sufferers.

• Sponsor organisation

  Novartis Consumer Health SA

• Eudract number

  2007-004316-31

• Research summary

  The primary objective of this trial is to compare how effective penciclovir (1%) cream is in preventing the development of Cold Sore blisters compared with that of a vehicle (a cream without the active ingredient). When a tingling or burning sensation is felt by the subject who is known to suffer from recurrent Cold Sores they will attend the research Site within 8 hours. Subjects who meet the inclusion and exclusion criteria and sign an informed consent will have a thermography assessment. For females a urine sample will be collected for pregnancy testing. Thermography will be used as an objective method of assessing the effectiveness of the penciclovir. It measures the skin temperature of the affected area and any increase of at least 0.5 C in comparison with the area on the opposite side of the face will be considered to be thermographically positive. The investigator will complete a clinical examination of the affected area. Subjects will be asked to complete a visual analogue scale VAS (a scale of 100mm on which they assess the level of pain felt) and also a 5 point scale (ranging from 0=no pain relief to 4= complete pain relief) were they will assess their overall pain relief from the study treatments. Subjects who are suitable for the entry into the study will receive either penciclovir cream or vehicle. They will be given a 2g tube of the study treatment which should be applied, firstly at the research site under supervision then every 2 hours during the waking day for 96 hours. They will record all the times they apply the creams in a diary at 2 time-points during the day (at lunch time and before going to bed). They will record their level of pain on the VAS and their overall pain relief 3 times a day for 96 hours. A total of 140 subjects will be randomised in the trial. They will have to return to the investigative site at 72 hours and 96 hours after the first application of the cream. At 72 hours they will have another thermographic assessment and clinical assessment of the affected area, pain assessment and diary review. These assessments will measure if the study treatment has prevented the development of blisters etc. usually seen with cold sores. At 96 hours the diaries will be reviewed and the used tube of study treatment will be weighed. Also a safety assessment will be done by the Investigator and for women a urine sample will be collected for a pregnancy test.

• REC name

  HSC REC B

• REC reference

  08/NIR02/90

• Date of REC Opinion

  27 Oct 2008

• REC opinion

  Further Information Favourable Opinion