Seborrheic dermatitis treatmenrt
By Jill Stein
RHODES, GREECE --
MAS064D cream is safe and effective for the management of mild to moderate seborrhoeic dermatitis (SD) of the face, according to results presented here at the 15th Congress of the European Academy of Dermatology and Venereology (EADV).MAS064D is a steroid-free cream that contains multiple active ingredients with anti-inflammatory properties and is approved in the European Union as a class II medical device.Stefano Veraldi, MD, specialist, department of dermatology and venereology, University of Milan, Milan, Italy, presented results in 60 adults who applied the MASO64D cream or a vehicle cream to the face 3 times per day for 28 days."Mainstream treatment options for SD include topical corticosteroids, topical and oral antimycotics, and a range of ointments, emollients and moisturizers, although the quality of evidence supporting their efficacy is often low," Dr. Veraldi said.The primary efficacy endpoint was the investigator's global assessment (IGA) score on day 28 compared with baseline (graded on a scale of 0 (clear) to 4 (severe). A score of 0 (clear) or 1 (almost clear) was classified as treatment success; a score of 2-4 (mild, moderate or severe, respectively) was classified as failure.Results showed that MADO64D had a high IGA success rate. A 4-week course of MAS064D was effective in 68% of 40 of the MASO64D group compared with 11% of 18 patients in the vehicle group (P < .0001), Dr. Veraldi noted.Reductions in erythema and desquamation scores between baseline and day 28 were significantly higher in the MAS064D group (P < .0001 and P < .01, respectively).For pruritus, MAS064D was significantly superior to vehicle at day 14 and 28. Scores on the Visual Analog Scale (VAS) show that patients rated pruritus as having decreased by 20 mm at day 14 and 28 in those receiving MASO46D, whereas vehicle-treated patients showed no or slight improvement in their perception of pruritus at both time points.Patients' assessment of global response between baseline and day 28 showed statistically significant improvement at days 14 and 28 for the MAS064D group (P < .01 and P < .0001, respectively).No patient in the MASO64D group required rescue medication compared with 2 in the vehicle group.Two patients in each group (5% MAS064D; 10% vehicle) reported a total of 6 non-serious adverse events. One patient stopped MAS064D due to a flare.Dr. Veraldi said the study is the first pilot, randomized, double-blind, parallel-open group, vehicle-controlled, phase 4 study of the efficacy and safety of MASO64D in the treatment of adult patients with mild to moderate SD of the face.Seborrheic dermatitis is an inflammatory disease of the skin characterized by erythema and scaling that is confined to areas such as the scalp, face, upper chest, shoulders, flexures, and pubis. The condition is frequently accompanied by itch.The study was sponsored by Sinclair Pharmaceuticals, Ltd and Chester Valley Pharmaceuticals, Inc.
RHODES, GREECE --
MAS064D cream is safe and effective for the management of mild to moderate seborrhoeic dermatitis (SD) of the face, according to results presented here at the 15th Congress of the European Academy of Dermatology and Venereology (EADV).MAS064D is a steroid-free cream that contains multiple active ingredients with anti-inflammatory properties and is approved in the European Union as a class II medical device.Stefano Veraldi, MD, specialist, department of dermatology and venereology, University of Milan, Milan, Italy, presented results in 60 adults who applied the MASO64D cream or a vehicle cream to the face 3 times per day for 28 days."Mainstream treatment options for SD include topical corticosteroids, topical and oral antimycotics, and a range of ointments, emollients and moisturizers, although the quality of evidence supporting their efficacy is often low," Dr. Veraldi said.The primary efficacy endpoint was the investigator's global assessment (IGA) score on day 28 compared with baseline (graded on a scale of 0 (clear) to 4 (severe). A score of 0 (clear) or 1 (almost clear) was classified as treatment success; a score of 2-4 (mild, moderate or severe, respectively) was classified as failure.Results showed that MADO64D had a high IGA success rate. A 4-week course of MAS064D was effective in 68% of 40 of the MASO64D group compared with 11% of 18 patients in the vehicle group (P < .0001), Dr. Veraldi noted.Reductions in erythema and desquamation scores between baseline and day 28 were significantly higher in the MAS064D group (P < .0001 and P < .01, respectively).For pruritus, MAS064D was significantly superior to vehicle at day 14 and 28. Scores on the Visual Analog Scale (VAS) show that patients rated pruritus as having decreased by 20 mm at day 14 and 28 in those receiving MASO46D, whereas vehicle-treated patients showed no or slight improvement in their perception of pruritus at both time points.Patients' assessment of global response between baseline and day 28 showed statistically significant improvement at days 14 and 28 for the MAS064D group (P < .01 and P < .0001, respectively).No patient in the MASO64D group required rescue medication compared with 2 in the vehicle group.Two patients in each group (5% MAS064D; 10% vehicle) reported a total of 6 non-serious adverse events. One patient stopped MAS064D due to a flare.Dr. Veraldi said the study is the first pilot, randomized, double-blind, parallel-open group, vehicle-controlled, phase 4 study of the efficacy and safety of MASO64D in the treatment of adult patients with mild to moderate SD of the face.Seborrheic dermatitis is an inflammatory disease of the skin characterized by erythema and scaling that is confined to areas such as the scalp, face, upper chest, shoulders, flexures, and pubis. The condition is frequently accompanied by itch.The study was sponsored by Sinclair Pharmaceuticals, Ltd and Chester Valley Pharmaceuticals, Inc.
posted by Madison @ 11:26 AM
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