Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks.

The primary response criterion is the number of patients with controlled disease at week 8.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Calcipotriene; Calcitriol

Criteria

Inclusion Criteria:

• Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week

• An investigators' global assessment of disease severity of at least mild

Exclusion Criteria:

• PUVA or Grenz ray therapy within 4 weeks prior to randomisation

• UVB therapy within 2 weeks prior to randomisation

• Systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within 6 months prior to randomisation

• Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation

• Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation

• Topical treatment for other relevant skin disorders (except WHO group I-II corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation

• Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis