Treatment success analysis as defined by IGA=0 or 1 and >2 grade reduction from baseline1
*primary endpoint; **Secondary endpoint
IGA=Investigator's Global AssessmentGet The Facts
1. Gold LS, Jackson JM, Knuckles MLF, Weiss JS. Improvement in extensive moderate plaque psoriasis with a novel emollient spray formulation of betamethasone dipropionate 0.05% J Drugs Dermatol. 2016;15(3):334-342.
SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Systemic effects of topical corticosteroids may also manifest as Cushing's syndrome, hyperglycemia or unmasking of latent diabetes mellitus, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Do not use if atrophy is present at the treatment site. Do not use with occlusive dressings. Avoid use on the face, scalp, axilla, groin or other intertriginous areas. Use of SERNIVO Spray is not recommended in pediatric patients as they are more susceptible to systemic toxicity. Allergic contact dermatitis may occur. The most common adverse reactions (≥1%) were application site pruritus, burning and/or stinging, pain, and atrophy. Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. These are not all the possible side effects of SERNIVO Spray. Please refer to Full Prescribing Information.
SERNIVO Spray is indicated for the treatment of mild-to-moderate plaque psoriasis in patients 18 years of age or older.
To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088.
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