A once-daily combination of calcipotriol plus betamethasone dipropionate was significantly more effective and better tolerated than twice-daily calcipotriol scalp solution in the treatment of scalp psoriasis.

The two-compound scalp formulation was well tolerated and more effective in the treatment of scalp psoriasis than either of its individual components in the same vehicle.

Background: There is a need for more effective therapy for scalp psoriasis. Objective: To assess the efficacy and safety of a 2-compound scalp formulation including calcipotriol and betamethasone dipropionate in the treatment of scalp psoriasis. Methods: Patients (n = 218) with scalp psoriasis were randomized to treatment with the 2-compound scalp formulation (n = 108) or betamethasone dipropionate in the same vehicle (n = 110). The treatments were applied once daily on the scalp for up to 8 weeks. Results: The 2-compound scalp formulation showed a significantly higher efficacy than betamethasone dipropionate on the total sign score at the end of treatment (p = 0.042) and after 2 weeks (p = 0.005). Conclusion: The calcipotriol plus betamethasone dipropionate scalp formulation was superior to betamethasone dipropionate in the same vehicle when used once daily for up to 8 weeks in the treatment of scalp psoriasis.

Registered as EudraCT no: 2007-005463-10.

The aim of the present study was to compare the effects of Daivobet® and calcipotriol on clinical score and biomarker responses in a modified version of the Scholtz-Dumas psoriasis plaque assay. Furthermore, it was the aim to compare the effects of calcipotriol and betamethasone in the murine psoriasis xenograft model. Twenty four patients with psoriasis were treated topically once daily for three weeks, whereas the grafted mice were treated for four weeks. Clinical responses were scored twice weekly and biopsies were taken at the end of each study to analyse for skin biomarkers by histology and immunohistochemistry. The results clearly demonstrate effects on both clinical signs and biomarkers. In the patient study the total clinical score was reduced significantly with both Daivobet® and calcipotriol. Both treatments reduced epidermal thickness, Ki-67 and cytokeratin 16 expression. T cell infiltration was significantly reduced by Daivobet® but only marginally by calcipotriol. Both treatments showed strong effects on the epidermal psoriatic phenotype.Results from the xenograft model essentially showed the same results. However differences were observed when investigating subtypes of T cells.The study demonstrates the feasibility of obtaining robust biomarker data in the psoriasis plaque test that correlate well with those obtained in other clinical studies. Furthermore, the biomarker data from the plaque test correlate with biopsy data from the grafted mice.

The optimised two-compound gels showed superior antipsoriatic effect over marketed betamethasone dipropionate solution. The results suggest that use of the psoriasis plaque test early in the development process can improve the development of topical formulations for dermatological use and can be a beneficial tool for selecting the most promising formulations for further clinical studies in psoriasis vulgaris.

Registered as EudraCT no: 2007-005463-10.

The effect of dydrogesterone on premenstrual symptoms was investigated in a double-blind, randomized, placebo-controlled study comprising 161 patients from unselected practice material. Dydrogesterone 10 mg twice daily from the 12th day until onset of the following menstrual period was compared with placebo throughout 3 cycles. No clinically relevant effect of dydrogesterone was found. There was an overall therapeutic effect in 52% of the patients on dydrogesterone, and in 44% of the placebo-treated patients. Therapeutic gain ranged between -7 and +23% (95% confidence limits). Type II error risk of failure to detect a therapeutic gain of 20% was 6%. A significant effect of dydrogesterone was found on decreased libido, and statistical significance was nearly achieved for the symptoms irritability and headache. The significant effect on libido can be attributed to mass significance.