Variables | Placebo | Aganirsen (0.86 mg/g) | Aganirsen (1.72 mg/g) |
---|---|---|---|
% Evolution in lesion area (visit 3)a | 24.5 ± 41.7 | −14.4 ± 38.6* | −12.9 ± 52.4* |
% Evolution in lesion area (visit 2) | 18.5 ± 30.9 | −18.8 ± 28.4** | −19.8 ± 31.4** |
TSS scoreb | |||
Baseline | 5.5 ± 1.0 | 5.7 ± 1.5 | 5.5 ± 1.2 |
6 weeks | 3.4 ± 1.2 | 3.6 ± 1.9 | 3.2 ± 1.3 |
PGAc | |||
Baseline | 2.5 ± 0.7 | 2.5 ± 0.8 | 2.5 ± 0.7 |
6 weeks | 3.7 ± 1.1 | 3.7 ± 1.2 | 3.9 ± 1.0 |
Toleranced | |||
Pruritus baseline | 0.3 ± 0.6 | 0.3 ± 0.6 | 0.3 ± 0.6 |
6 weeks | 0.2 ± 0.6 | 0.2 ± 0.6 | 0.2 ± 0.6 |
Change in irritation | 0 ± 0 | 0 ± 0 | 0 ± 0 |
Change in burning | 0 ± 0 | 0 ± 0 | 0 ± 0 |
Change in exudation | 0 ± 0 | 0 ± 0 | 0 ± 0 |
Change in itching after 6 weeks | |||
−1 | 1 (8.3%) | 1 (8.3%) | 1 (8.3%) |
0 | 10 (83.3%) | 10 (83.3%) | 10 (83.3%) |
2 | 1 (8.3%) | 1 (8.3%) | 1 (8.3%) |
↵a Percentage evolution (mean ± S.D.) between week 6 (visit 3) and week 3 (visit 2) and baseline (visit 1) in area of treated psoriasis plaque as measured by photography; two types of diameters were measured, both at baseline, 3 weeks, and 6 weeks after treatment: sum of diameters (mm) from the Case Report Form and diameters (cm) as measured on pictures.
↵b TSS: sum of signs (redness/erythema, scale/crusting, thickening/elevation) and symptoms (pruritus) using 4-point scales (e.g., none/clear = 0, mild = 1, moderate = 2, extensive = 3). Score varies from 0 to 12 for each lesion.
↵c For PGA, three items were noted: erythema, induration, and scale, according to Feldman and Krueger (2005).
↵d Local tolerance of treatment: patient’s assessment on a 4-point scale of irritation, itching, pruritus, sensation of burning, and exudation.
↵* P < 0.05 vs. placebo; **P < 0.01 vs. placebo.