Page 9 - Betesil-12pp-V3

Clinical Studies

Comparable efficacy after 4 weeks of treatment

-0.610 -0.288 0.034
Difference between the adjusted
TSS-4** scores BETESIL versus
Betamethasone / Calcipotriol

-1 0 1
Non inferiority margin

• Non-significant difference
• CI*** 95% >-1 (non-inferiority margin)
BETESIL is non inferior to the combination of Betamethasone 0.5 mg -
Calcipotriol 50 μg/ g

Equivalent safety
• Safety is equivalent for both treatment groups, with the proportion of patients with adverse
effects in the BETESIL group being 8.48% (165 patients, ITT population), and in the
combination of Betamethasone / Calcipotriol group being 9.43% (159 patients, ITT population)
• The most common adverse effect was nasopharyngitis (2 patients in the BETESIL group and
4 in the Betamethasone/Calcipotriol group)
• Only 1 side effect is related to treatment (burning sensation) in the BETESIL group

* PP: Per protocol.
* * TSS-4: 4-item Total Severity Score: redness/erythema, scale/crusting, thickening/elevation
of plaques, pruritus.

* * * CI - Confidence Interval

2.250 mg medicated plaster
Betamethasone valerate