Encore Dermatology Inc. Announces Results From Pivotal Study Evaluating Impoyz™ (clobetasol propionate) Cream, 0.025% for the Treatment of Moderate to Severe Plaque Psoriasis
MALVERN, Pa.--(BUSINESS WIRE)--Jan 30, 2019--The announcement was made today, at the 15 th annual Maui Derm Conference, that Impoyz Cream demonstrated efficacy early, with 14.2% of Impoyz patients achieving treatment success at day 8 versus 1.6% in the vehicle group. Treatment success was achieved when subjects received a “clear” or “almost clear” assessment, marking at least a 2-grade improvement from their baseline assessment. Efficacy continued during the second week of treatment with 30% of subjects in the Impoyz group achieving treatment success compared to only 9% in the vehicle group by day 15.
The primary objective of this trial was to evaluate the efficacy and safety of Impoyz™ (clobetasol propionate) Cream, 0.025% for the treatment of moderate to severe plaque psoriasis in adults 18 years of age and older.
The only adverse reaction reported in the Impoyz group that occurred in at least 1% of subjects treated and was at a higher incidence than the vehicle cream was application site discoloration, 2% versus 1%. Rare adverse events occurring in <1% of subjects treated with Impoyz included application site atrophy, telangiectasia and rash.
“The efficacy Impoyz demonstrated in just 2 weeks is notable considering these were patients with moderate to severe plaque psoriasis at baseline,” says dermatologist Seemal R. Desai, M.D., a lead investigator in the study. “Impoyz also provides some comfort based on the low incidence of adverse events reported which is also favorable.”
The study was a phase 3, randomized, double-blind, vehicle controlled, multicenter trial involving 265 patients with moderate to severe plaque psoriasis. Subjects were randomized (2:1) to treatment with Impoyz Cream or vehicle cream and instructed to apply study product twice daily for 15 consecutive days. Follow-up visits where efficacy was measured were scheduled at day 8, and day 15 of treatment.
“Impoyz Cream offers providers a great alternative to traditional high-potency topical steroids,” says Bob Moccia, President and CEO of Encore Dermatology. “This study helps illustrate Impoyz Cream’s core benefit which is to reduce the likelihood of adverse effects while maintaining favorable efficacy.”
About Impoyz™ (clobetasol propionate) Cream, 0.025%
Impoyz Cream is indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. Impoyz is packaged in a 60g tube and is available in the U.S. by prescription only.
Important Safety Information for Impoyz TM (clobetasol propionate) Cream, 0.025%
Topical corticosteroids, including Impoyz Cream, can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. This may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose to HPA axis suppression include use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. If HPA axis suppression occurs, gradually withdraw the drug, reduce frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of withdrawal occur, systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Although rare, systemic effects of topical corticosteroids may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria.
Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios.
Local adverse reactions from topical corticosteroids may be more likely to occur with occlusion, prolonged use, or use of higher-potency corticosteroids. Some local adverse reactions may be irreversible.
Use an appropriate antimicrobial agent if a skin infection is present or develops. If appropriate, discontinue use of Impoyz Cream.
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation.
Please see Full Prescribing Information for additional information at www.encorederm.com.
About Encore Dermatology Inc.
Headquartered in Malvern, Pennsylvania, Encore Dermatology is a privately held, fully integrated specialty dermatology company committed to delivering innovative prescription therapies and medical devices to dermatologists while focusing on customer service and improving the quality of life of patients. In addition to the founders, Encore Dermatology’s principal investors are Essex Woodlands, 1315 Capital and Longitude Capital.
To learn more about Encore Dermatology, please visit www.encorederm.com
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CONTACT: Kent Taylor
Malvern, PA 19355
KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA
INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS PHARMACEUTICAL GENERAL HEALTH
SOURCE: Encore Dermatology Inc.
Copyright Business Wire 2019.
PUB: 01/30/2019 02:47 PM/DISC: 01/30/2019 02:47 PM