Study product |
Indication |
Objective |
N |
Admin. frequency |
Comparator |
Results vs comparator |
MF 0.1 %
O/W 33 % water content
Cream |
Healthy
Skin [12] |
Bioavailability
(VCA) |
31 |
Single
application |
Vehicle |
Superiority |
Class II lower strength |
Non-inferiority |
Mometasone comparator |
Non-inferiority |
Class IV higher strength |
Non-inferiority
(not confirmed) |
Tolerability |
33 |
QD
21 days |
Vehicle |
|
Purified water (negative control) |
Higher irritation score |
SDS (positive control) |
Lower irritation score |
Plaque
Psoriasis [12] |
Efficacy |
22 |
QD
12 days |
Vehicle |
Superiority |
Mometasone comparator |
Comparable |
Atopic
Dermatitis [67] |
Efficacy
QoL
Patient
satisfaction |
20 |
QD
2 weeks |
Mometasone comparator |
Comparable efficacy
Better cosmetic traits
and
patient satisfaction |
MF 0.1 %
36 % water content
Emulsion |
Plaque
Psoriasis [68] |
Efficacy andÂ
Tolerability |
24 |
QD
12 days |
Placebo emulsion |
Superiority |
Reference product cream |
Comparable |
Chronic Scalp Psoriasis [69] |
Efficacy |
70 |
QD
3 weeks |
Reference product solution |
Non-inferiority |
QD: Once daily; Mometasone comparator: the originator mometasone furoate 0.1 % cream formulation (water content <5 %); Class II: 1 mg/g of triamcinolone acetonide
(water content 72.2 %); Class IV: 0.5 mg/ml of clobetasol-17-propionate (water content 30.8 %); SDS: 0.3 % sodium dodecyl sulfate in water