TABLE 2

Study clinical endpoints

VariablesPlaceboAganirsen (0.86 mg/g)Aganirsen (1.72 mg/g)
% Evolution in lesion area (visit 3)a24.5 ± 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
 Baseline5.5 ± 1.05.7 ± 1.55.5 ± 1.2
 6 weeks3.4 ± 1.23.6 ± 1.93.2 ± 1.3
PGAc
 Baseline2.5 ± 0.72.5 ± 0.82.5 ± 0.7
 6 weeks3.7 ± 1.13.7 ± 1.23.9 ± 1.0
Toleranced
 Pruritus baseline0.3 ± 0.60.3 ± 0.60.3 ± 0.6
 6 weeks0.2 ± 0.60.2 ± 0.60.2 ± 0.6
 Change in irritation0 ± 00 ± 00 ± 0
 Change in burning0 ± 00 ± 00 ± 0
 Change in exudation0 ± 00 ± 00 ± 0
 Change in itching after 6 weeks
  −11 (8.3%)1 (8.3%)1 (8.3%)
  010 (83.3%)10 (83.3%)10 (83.3%)
  21 (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.