title: Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study.
abstract: BACKGROUND
  Topical antifungals and corticosteroids are the mainstay of treatment for seborrhoeic dermatitis. The short-contact clobetasol propionate 0·05% shampoo (CP) is an efficacious and safe once-daily treatment for scalp psoriasis.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of CP alone and combined with ketoconazole shampoo 2% (KC) in the treatment of moderate to severe scalp seborrhoeic dermatitis.
  
  
  METHODS
  This randomized and investigator-blinded study consisted of three phases, each lasting 4 weeks. During the treatment phase, subjects were randomized to receive KC twice weekly (K2), CP twice weekly (C2), CP twice weekly alternating with KC twice weekly (C2 + K2) or CP four times weekly alternating with KC twice weekly (C4+K2). All subjects received KC once weekly during the maintenance phase and were untreated during the follow-up phase.
  
  
  RESULTS
  At the end of the treatment phase, all three CP-containing regimens were significantly more efficacious than K2 in decreasing the overall disease severity (P < 0·05). Both combination regimens were also significantly more efficacious than K2 in decreasing each individual sign of the disease (P < 0·05). While the C2 and C4 + K2 groups experienced slight worsening during the maintenance phase, the efficacy of C2 + K2 was sustained and remained the highest among all groups. All regimens were well tolerated without inducing any skin atrophy. Similarly low incidences of telangiectasia, burning and adverse events were observed among the four groups.
  
  
  CONCLUSIONS
  The combination therapy of twice-weekly CP alternating with twice-weekly KC provided significantly greater efficacy than KC alone and a sustained effect in the treatment of moderate to severe scalp seborrhoeic dermatitis.
authors.affiliation: Hôpital de l'Archet 2, 06202 Nice Cedex 3, France. ortonne@unice.fr
authors.forename: J-P
authors.initials: JP
authors.lastname: Ortonne
authors.forename: A F
authors.initials: AF
authors.lastname: Nikkels
authors.forename: K
authors.initials: K
authors.lastname: Reich
authors.forename: R M
authors.initials: RM
authors.lastname: Ponce Olivera
authors.forename: J H
authors.initials: JH
authors.lastname: Lee
authors.forename: N
authors.initials: N
authors.lastname: Kerrouche
authors.forename: F
authors.initials: F
authors.lastname: Sidou
authors.forename: J
authors.initials: J
authors.lastname: Faergemann
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000627:therapeutic use*; D002990:Clobetasol / Q000627:therapeutic use*; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000473:pathology; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007654:Ketoconazole / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index
chemical_list: D000893:Anti-Inflammatory Agents; D000935:Antifungal Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D002990:Clobetasol; D007654:Ketoconazole