title: Treatment of seborrhoeic dermatitis of the scalp with a topical solution of urea, lactic acid, and propylene glycol (K301): results of two double-blind, randomised, placebo-controlled studies.
abstract: Alternative treatments for seborrhoeic dermatitis are needed because of the increasing risk of anti-fungal resistance to existing therapies. To investigate the efficacy, safety and tolerability of topical scalp treatment with K301 solution. Two multi-centre, randomised, double-blind studies were conducted. Study I: 4 weeks of once-daily treatment with either one form of K301 (a or b) or placebo, followed by 4 weeks of maintenance treatment three times-per-week. Study II: 4 weeks of K301 (a) or placebo once-daily. Study I: 98 patients enrolled (K301a + b, n = 51; placebo, n = 47) and 83 completed; 201 entered Study II (K301a, n = 136; placebo, n = 65) and 195 completed. Erythema and desquamation sum score at 4 weeks, mean (SD) values were 2.4 (2.0) for K301a + b and 3.2 (2.2) for placebo in Study I (P = 0.025) and 2.5 (1.9) for K301a and 3.2 (1.8) for placebo in Study II (not significant). In both studies, 4-week desquamation scores were significantly improved for K301 vs. placebo (P < 0.05). Both studies showed significant improvements in symptomatic investigator and patient assessments for K301 over placebo after 4 weeks (P < 0.05). Treatment-related adverse events were generally mild and included some smarting or burning upon application. The K301 was well tolerated and associated with clinically meaningful improvements in seborrhoeic dermatitis endpoints.
authors.affiliation: Department of Dermatology & Venereology, Karolinska University Hospital, Stockholm, Sweden. lennart.emtestam@ki.se
authors.forename: Lennart
authors.initials: L
authors.lastname: Emtestam
authors.forename: Åke
authors.initials: Å
authors.lastname: Svensson
authors.forename: Kjell
authors.initials: K
authors.lastname: Rensfeldt
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019344:Lactic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D019946:Propylene Glycol / Q000008:administration & dosage* / Q000009:adverse effects; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014508:Urea / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D010919:Placebos; D019344:Lactic Acid; D019946:Propylene Glycol; D014508:Urea