SORILUX Foam delivers effective, steroid-free treatment for plaque psoriasis of the body
SORILUX Foam was evaluated as monotherapy for mild-to-moderate plaque psoriasis of the body in 2 multicenter, randomized, double-blind, vehicle-controlled, Phase III studies including 659 patients aged 12 to 89 years (10 patients were <18 years of age). 1
Study design 1
- At baseline, patients were required to have plaque psoriasis with an Investigator’s Static Global Assessment (ISGA) score of 2 (mild) or 3 (moderate) on a 5-point scale for erythema, thickness, and scaliness
- At baseline, 71% of patients had moderate psoriasis and 29% of patients had mild psoriasis
- Patients were instructed to self-administer SORILUX Foam or vehicle foam as monotherapy twice daily, morning and evening, for 8 weeks
Treatment success was defined as an ISGA score of clear (0) or almost clear (1) AND at least a 2-grade improvement in the ISGA score from baseline to week 8. 2
- Patients with mild psoriasis (ISGA score 2) at baseline needed to be graded as clear (ISGA score 0) at week 8 to achieve treatment success
Think you know calcipotriene? Look again.
SORILUX Foam—photos of actual patients who achieved treatment success in clinical trials
Actual patients from clinical trials, who are representative of patients who achieved treatment success. Individual results may vary.
FDA approval of SORILUX Foam was based on the totality of clinical evidence, including 2 Phase III studies
Patients graded as mild at baseline showed a greater response to vehicle foam than SORILUX Foam (3/34 and 2/73, respectively).
Because the overall treatment success rate in Study 1 did not achieve statistical significance, P values are not included for patients with mild or moderate psoriasis.
The proportion of patients who achieved treatment success with SORILUX Foam in Study 2 was statistically significant for all patients and for patients with moderate psoriasis of the body when compared with vehicle foam.
Rate of adverse reactions was similar between patients using SORILUX Foam and patients using vehicle foam
APPLICATION SITE REACTIONS FROM 2 PIVOTAL STUDIES FOR PLAQUE PSORIASIS OF THE BODY 1
|THE MOST FREQUENT ADVERSE REACTIONS REPORTED BY >1% OF PATIENTS IN CLINICAL STUDIES||SORILUX FOAM
|Application site erythema||2%||1%|
|Application site irritation||2%||1%|
|Application site pruritus||2%||3%|
References: 1. Feldman SR, Matheson R, Bruce S, et al; U0267-301 & 302 Study Investigators. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials. Am J Clin Dermatol. 2012;13(4):261-271. 2. SORILUX Foam [package insert]. Greenville, NC: Mayne Pharma; 2016.