Page 6 - Betesil-12pp-V3

Clinical Studies

NALDI Study in plaque psoriasis : BETESIL more
(2)
efficacious than Betamethasone Cream 0.1%

A Prospective and controlled study
International, multi-centre, prospective, randomised, assessor-blind, parallel group,
active-controlled phase III study comparing BMV plaster 0.1% versus Betamethasone valerate
0.1% cream.
Objective
To evaluate the efficacy and safety of BETESIL and Betamethasone valerate cream 0.1% in
patients with mild-to-moderate chronic plaque psoriasis.
Study Diagram

Visit D0 D7 D14 D21 D35 3 months
Day PGA = 0/1
Discontinue treatment
BETESIL
Once a day (n = 116)
PGA > 1 Continuation PGA = 0/1
of treatment Discontinue treatment and follow up
1:1 PGA > 1
Randomised Start alternative treatment
PGA = 0/1
Discontinue treatment
Betamethasone Valerate Cream 0.1 %
Twice a day (n = 114)
PGA > 1 Continuation PGA = 0/1
of treatment Discontinue treatment and follow up
PGA > 1
230 patients included (ITT*) Start alternative treatment
• Adults ≥ 18
• Diagnosis of stable, chronic plaque psoriasis on <10% of the body surface area
• 2 to 4 plaques on elbows and / or knees on a surface of 10 to 150 cm 2
• Exclusion of patients requiring systemic treatment for psoriasis

Outcome measures
Number of patients with cleared plaques (PGA score **= 0) after 3 weeks of treatment (ITT*)

BETESIL like other potent steroids, is a first-line treatment in plaque
psoriasis excluding sensitive areas (face and skin folds).
Once a significant improvement has been achieved, it may be replaced by another form of less
potent corticosteroid.