Calcipotriol+BetamethasoneDipropionateGel scalp/body psoriasis 12-16yr
Research type
Research Study
Full title
Effect of Calcipotriol plus Betamethasone Dipropionate gel on the HPA axis and calcium metabolism in adolescent subjects (aged 12 to 16 years, 11 months)with scalp and body psoriasis
IRAS ID
140059
Contact name
Anthony Bewley
Contact email
Eudract number
2013-001538-16
Research summary
Psoriasis is a common skin disease featuring thickened, red, scaly patches of skin which may itch. Common locations include the knees, elbow, scalp and trunk. Psoriasis is a disabling disease, with a significant impact on the quality of life. Around 25% of psoriasis patients are diagnosed between 10-19 years of age and scalp involvement is more prevalent in the 12-17 year age group.
LEO 80185 gel is a combination product containing calcipotriol 50 mcg/g and betamethasone dipropionate 0.5 mg/g, developed for topical treatment of scalp and body 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 gel vehicle or scalp solution) and gel vehicle alone in the treatment of scalp psoriasis. LEO 80185 gel (under the trade names Daivobet®/Dovobet®/Taclonex®) has marketing approval in many countries for the treatment of both scalp and body psoriasis in adults. Two safety studies with this product have been conducted in patients under 18 years old with scalp psoriasis, but none in adolescents with both scalp and body psoriasis.
100 patients will be recruited from UK, France, Germany, USA, Canada and Australia; 15 from UK. The primary purpose of the study is to assess the safety and efficacy of calcipotriol and betamethasone dipropionate gel in adolescent patients with scalp and body psoriasis. Participants will attend 2 screening visits. Every eligible patient will then receive LEO 80185 gel, applying it once daily for up to 8 weeks, attending up to 5 visits for psoriasis assessments. There may be a 2 week follow up period if adverse events are ongoing at the end of treatment that could be due to the gel.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0006
Date of REC Opinion
27 Jan 2014
REC opinion
Further Information Favourable Opinion