Treatment of mild to moderate seborrhoeic dermatitis with MAS064D (Sebclair), a novel topical medical device: results of a pilot, randomized, double-blind, controlled trial.
OBJECTIVE
MAS064D (Sebclair) is a novel steroid-free cream containing multiple active ingredients. Objective of this pilot study was to evaluate the efficacy and safety of MAS064D in the treatment of mild to moderate SD of the face.


METHODS
Patients (n = 60) with SD were randomized to receive MAS064D (n = 40) or a matching vehicle (n = 20). The primary study endpoint was investigators' global assessment (IGA) score at day 28, compared with baseline. Secondary endpoints included: IGA score at day 14; investigators' assessment of erythema and scaling; patients' assessment of burning/stinging, pruritus and global response to MAS064D; resort to rescue medication; quality of life.


RESULTS
Use of MAS064D for 4 weeks was associated with a higher percentage of success in the MAS064D group than in the vehicle group (approximately 68% vs 11%, P < 0.0001). The effects of MAS064D were significantly better than those of vehicle for investigator-assessed erythema and scaling, and patients' assessed pruritus and global response to MAS064D (P 0.01). No patient in the MAS064D group required rescue medication, compared with two patients in the vehicle group. Four patients (two each in the MAS064D and vehicle groups) reported a total of six non-serious adverse events.


CONCLUSIONS
MAS064D appears to be an effective and well tolerated cream for the treatment of mild to moderate SD of the face. Further clinical evaluation of MAS064D in SD is warranted.
Veraldi
S
S
Institute of Dermatological Sciences, University of Milan, IRCCS Foundation, Policlinico, Mangiagalli, Italy. stefano.veraldi@unimi.it
Menter
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A
Innocenti
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D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000473:Alkanes / Q000008:administration & dosage* / Q000009:adverse effects; D000481:Allantoin / Q000008:administration & dosage* / Q000009:adverse effects; D012628:Dermatitis, Seborrheic / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000081222:Monocyclic Sesquiterpenes; D009824:Ointments; D010865:Pilot Projects; D011728:Pyridones / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012717:Sesquiterpenes / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D053778:Thiazolidines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014810:Vitamin E / Q000008:administration & dosage* / Q000009:adverse effects
D000473:Alkanes; D003879:Dermatologic Agents; D004338:Drug Combinations; D004983:Ethanolamines; D000081222:Monocyclic Sesquiterpenes; D009824:Ointments; D011728:Pyridones; D012717:Sesquiterpenes; D053778:Thiazolidines; C091508:telmesteine; D014810:Vitamin E; C004497:bisabolol; D000481:Allantoin; C059167:2,2,4,4,6,8,8-heptamethylnonane; C052599:piroctone olamine