Encore Dermatology, Inc. Announces Phase 2 Safety Data Demonstrating Lower Systemic Drug Exposure With Impoyz™ (clobetasol propionate) Cream, 0.025% Compared to Temovate® (clobetasol propionate) Cream, 0.05%
MALVERN, Pa.--(BUSINESS WIRE)--Nov 27, 2018--Encore Dermatology, Inc. today announced the publication of a Phase 2, open-label study in SKIN The Journal of Cutaneous Medicine. Subjects treated with Impoyz (clobetasol propionate) Cream, 0.025% showed significantly lower mean post-treatment clobetasol propionate plasma concentrations versus the subjects treated with Temovate® (clobetasol propionate) Cream, 0.05% (56.3 vs 152.5 pg/mL, P =0.014). Both treatment groups evidenced similar improvements in global psoriasis severity as measured by improvements in the Investigator’s Global Assessment (IGA) from baseline to Day 15. As a result, compared with traditional-dose formulations of clobetasol propionate (0.05%), this data suggests that Impoyz Cream may provide a better safety profile without compromising efficacy. A link to the online article can be accessed here.
Additionally, a lower proportion of subjects in the Impoyz Cream group (12.5%) experienced HPA axis suppression compared to those in the Temovate Cream group (36.4%), although this did not reach statistical significance ( P =0.086).
“Impoyz Cream is the first topical clobetasol offering an alternative to the traditional 0.05% clobetasol concentrations, allowing dermatology providers greater flexibility when prescribing high-potency topical corticosteroids,” said Bob Moccia, president and CEO of Encore Dermatology.
The study is a randomized, multicenter, multidose, comparator controlled, open-label study in 50 subjects with moderate to severe plaque psoriasis involving 20% to 50% of the body surface area (BSA) at baseline, not including the face, scalp, groin, axillae, and other intertriginous areas. Subjects were randomized (1:1) to treatment with Impoyz Cream or Temovate Cream and instructed to apply study product twice daily for 15 days. The primary safety assessments were the potential for HPA axis suppression and the mean post-treatment clobetasol propionate plasma concentrations before and after the 15-day treatment period.
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 60 g 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.
The adverse reaction that occurred in at least 1% of subjects treated with IMPOYZ Cream and at a higher incidence than in subjects treated with vehicle cream was application site discoloration (2% versus 1%). Less common local adverse events occurring in < 1% of subjects treated with IMPOYZ Cream were application site atrophy, telangiectasia and rash.
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
Temovate® Cream is registered trademark of PharmaDerm®, a division of Fougera Pharmaceuticals Inc.
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CONTACT: Kent Taylor
KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA
INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS PHARMACEUTICAL OTHER HEALTH
SOURCE: Encore Dermatology, Inc.
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PUB: 11/27/2018 08:25 AM/DISC: 11/27/2018 08:25 AM