Scalp Psoriasis

Scalp Psoriasis

Scalp psoriasis

SORILUX Foam delivers effective, steroid-free treatment for scalp psoriasis

SORILUX Foam was evaluated as monotherapy for treatment of moderate plaque psoriasis of the scalp in a multicenter, randomized, double-blind, vehicle-controlled study in 363 patients aged 12 to 97 years (11 patients were <18 years). 1

Study design 2

  • At baseline, patients were required to have ≥10% involvement of the total scalp surface area with an Investigator’s Static Global Assessment (ISGA) score of 3 (moderate) on a 6-point scale for erythema, thickness, and scaliness
  • 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 0 (clear) or 1 (almost clear) at week 8. 3

Think you know calcipotriene? Look again.

SORILUX Foam—photos from clinical trials


Baseline And 8 Weeks Scalp Results Photo Of An Actual Patient Who Achieved Treatment Success With SORILUX Foam

Baseline And 8 Weeks Scalp Results Photo Of An Actual Patient Who Achieved Treatment Success With SORILUX Foam

Actual patient from clinical trials with moderate plaque psoriasis (ISGA score 3) at baseline, representative of patients who achieved treatment success. Individual results may vary.

In a Phase III clinical study of moderate-severity scalp psoriasis, SORILUX Foam monotherapy achieved significant results when compared with vehicle foam 1

At week 8, 41% of patients treated with SORILUX Foam achieved treatment success compared with 24% of patients treated with vehicle foam ( P<0.001). 1

Bar Graph Illustrating 41% Of Patients Treated With SORILUX Foam Achieved Success Compared To 24% Of Patients Treated With Vehicle Foam

SORILUX Foam was well tolerated. The rate of adverse events was similar to that of vehicle foam.

APPLICATION SITE REACTIONS FROM THE PIVOTAL STUDY FOR PLAQUE PSORIASIS OF THE SCALP 2

ADVERSE EVENTS REPORTED IN >2% OF PATIENTS SORILUX FOAM
(N=181)
VEHICLE FOAM
(N=182)
Application site pain 4% 3%
Application site pruritus 4% 4%
Application site erythema 3% 0%

References: 1. Feldman SR, Eastman WJ, Brundage T, Mills M. A multicenter, randomized, double-blind study of the efficacy and safety of calcipotriene foam, 0.005%, vs vehicle foam in the treatment of plaque-type psoriasis of the scalp. J Drugs Dermatol. 2013;12(3):300-306. 2. Data on file. Greenville, NC; Mayne Pharma LLC. 3. SORILUX Foam [package insert]. Greenville, NC: Mayne Pharma; 2019.

Indication

SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years and older.

For more information, please see full Prescribing Information and Patient Information Leaflet

Important Safety Information

  • SORILUX Foam should not be used by patients with known hypercalcemia
  • The propellant in SORILUX Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application
  • Transient, rapidly reversible elevation of serum calcium has occurred with use of calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored
  • SORILUX Foam is not for oral, ophthalmic, or intravaginal use
  • Adverse reactions reported in ≥1% of subjects treated with SORILUX Foam and at a higher incidence than subjects treated with vehicle were application site erythema (2%) and application site pain (3%). The incidence of these adverse reactions was similar between the body and scalp

Medical Information & Adverse Drug Events Reporting

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.