Primary Efficacy Results

  • Absolute change in comedonal lesion counts with ONEXTON Gel was -19.2 vs -9.6 for vehicle (P<0.001)1,2
  • Absolute change in inflammatory lesion counts with ONEXTON Gel was -16.3 vs -8.2 for vehicle (P<0.001)1,2
  • 35% of patients experienced treatment success (n=253) vs 17% with vehicle (n=245) (P<0.001)1,2

Treatment success=at least a 2-grade improvement in EGSS at Week 12.2

EGSS=Evaluator’s Global Severity Score.1,2

EGSS scale: 0 (clear); 1 (almost clear); 2 (mild); 3 (moderate); 4 (severe); 5 (very severe).1,2

SIGNIFICANT COMEDONAL MEAN LESION REDUCTIONS IN A CLINICAL TRIAL1-3

Post hoc results

Teen females

0.0%
(n=60)

vs vehicle 24.9%
(n=55)
P<0.001

Teen males

0.0%
(n=95)

vs vehicle 15.9%
(n=79)
P<0.001

Adult females§

0.0%
(n=29)

vs vehicle 34.0%
(n=43)
P=0.020

Severe patients

0.0%
(n=41)

vs vehicle 21.1%
(n=45)
P=0.001

  • Onexton
  • Vehicle

Post hoc analysis of the results of a Phase 3, multicenter, randomized, double-blind, vehicle-controlled group study comparing the efficacy and safety of ONEXTON Gel once daily for 12 weeks with vehicle gel in patients 12 years and older with moderate to severe acne vulgaris (baseline 20-100 comedonal lesions).1,2

‡ ≥12 and <18

§ ≥25

SIGNIFICANT INFLAMMATORY MEAN LESION REDUCTIONS IN A CLINICAL TRIAL1-3

Post hoc results

Teen females

0.0% (n=60)

vs vehicle 18.2%
(n=55)
P<0.001

Teen males

0.0% (n=95)

vs vehicle 23.7%
(n=79)
P<0.001

Adult females§

0.0% (n=29)

vs vehicle 39.7%
(n=43)
P=0.019

Severe patients

0.0% (n=41)

vs vehicle 19.2%
(n=45)
P<0.001

  • Onexton
  • Vehicle

Post hoc analysis of the results of a Phase 3, multicenter, randomized, double-blind, vehicle-controlled group study comparing the efficacy and safety of ONEXTON Gel once daily for 12 weeks with vehicle gel in patients 12 years and older with moderate to severe acne vulgaris (baseline 20-40 inflammatory lesions).1,2

‡ ≥12 and <18

§ ≥25