Calcipotriol plus betamethasone in adolescents with scalp psoriasis

• Research type

  Research Study

• Full title

  Safety and efficacy of Calcipotriol plus Betamethasone dipropionate gel in adolescent patients (aged 12 to 17 years) with scalp psoriasis

• IRAS ID

  31729

• Contact name

  Alexander Anstey

• Sponsor organisation

  LEO Pharma A/S

• Eudract number

  2008-005456-24

• ISRCTN Number

  N/A

• Research summary

  Psoriasis is a common skin disease characterised by thickened, red and scaly patches of skin which may itch. It is more common on the body and the limbs but is also found on the scalp, face and occluded areas, e.g. armpits. The scalp is one of the most common sites for psoriasis, causing psychological and social incapacity. Involvement of the scalp has been reported to occur in 53-79% of psoriasis patients. LEO80185 gel is a combination product containing calcipotriol 50 mcg/g & betamethasone dipropionate 0.5 mg/g developed for topical treatment of scalp psoriasis. The results from five phase 3 studies in adults (4 in UK, 1 in USA) have showed that LEO 80185 gel is significantly more effective than using betamethasone dipropionate in gel vehicle, calcipotriol (in the gel vehicle or as the marketed scalp solution) & the gel vehicle alone in the treatment of scalp psoriasis. LEO 80185 gel has marketing approval in many countries for the treatment of scalp psoriasis in adults. No studies with this product have been conducted in patients under 18 years of age. The study is being undertaken as a post-marketing commitment to the FDA. This study will run in the UK & France, where 70 participants will be recruited. The main purpose of this study is to assess the safety of calcipotriol & betamethasone dipropionate gel in adolescent patients with scalp psoriasis. This study will be open-label with no comparator. The study will involve an 8 week treatment period for eligible patients, during which study medication will be applied once daily. Participants will attend 2 screening visits followed by 5 visits for assessment of their psoriasis. Participants may then have a 2 week follow up period if they have adverse events ongoing at the end of their treatment that have a possible/probable/unknown relationship to the gel.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/24

• Date of REC Opinion

  22 Apr 2010

• REC opinion

  Further Information Favourable Opinion