An antifungal shampoo for the treatment of severe dandruff

• Research type

  Research Study

• Full title

  A double-blind, placebo-controlled study determining the efficacy of terbinafine shampoo in the treatment of pityriasis capitis and seborrhoeic dermatitis.

• IRAS ID

  97193

• Contact name

  Terrina Dickson

• Sponsor organisation

  Dermal Laboratories

• Eudract number

  2011-000852-40

• Research summary

  The aim of the study is to test a new antifungal shampoo for the treatment of 2 commmon scalp conditions; pityriasis capitis and seborrhoeic dermatitis, which are thought to affect around 5% of the population, with up to half of the world's population suffering from some form of dandruff. These conditions are thought to be caused by overgrowth of a form of yeast, which is present on the skin. Current treatments consist of a range of antidandruff shampoos and lotions with active ingredients such as coal tar, salicylic acid and selenium sulphide, antifungal ingredients such as ketoconazole, or for more severe cases corticosteroids may be used. However, these treatments are not effective for all patients, and so a new shampoo with an antifungal active ingredient was developed by the Sponsor. This active ingredient has well established antifungal properties, demonstrated by a number of years' use in a treatment for other fungal skin infections, that make it suitable for the treatment of pityriasis capitis and sebhorrhoeic dermatitis. The new shampoo will be tested in a clinical study involving approximately 114 patients suffering from the two scalp conditions. The study will take place in a single study centre, where patients will have their hair washed twice weekly by trained technicians, using the new shampoo or placebo shampoo for a 4 week treatment period, after a 2 week washout period. Patients will also be allowed to use Johnson's Baby Shampoo at home to maintain their normal hair washing regime during their time in the study. The primary outcome of the study is the change in overall dandruff severity score from baseline, which is based on the extent of skin flaking visible on the scalp, as assessed by a trained scalp assessor.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  12/ES/0060

• Date of REC Opinion

  31 Jul 2012

• REC opinion

  Further Information Favourable Opinion