Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: results of a double-blind, vehicle-controlled trial.

Seborrheic dermatitis is a common inflammatory skin disorder. Yeasts of the genus Malassezia have been implicated in the etiology of seborrheic dermatitis, although this connection remains controversial. Ciclopirox is a synthetic, hydroxypyridone-derived, broad-spectrum antifungal agent with anti-inflammatory properties.
A total of 499 US patients with seborrheic dermatitis of the scalp were randomized to apply either ciclopirox shampoo 1% or vehicle twice weekly for 4 weeks. The main efficacy parameters were based on 6-point ordinal scales describing the disease's signs and symptoms (scaling, erythema and itching) and a 6-point scale providing a global evaluation of the status of seborrheic dermatitis.
Ciclopirox was significantly better than vehicle in effectively treating seborrheic dermatitis. 'Effective treatment' (score of 0 or 1 for disease status, scaling and erythema) was achieved in 26.0% of ciclopirox-treated patients compared with 12.9% of vehicle-treated patients (P = 0.0001; OR: 2.383, 95% CI: 1.494-3.799). The majority of subjects experienced adverse events that were mild in intensity, with skin and appendage reactions the most commonly reported, at similar frequency in both groups.
Ciclopirox shampoo 1% is effective and safe in the treatment of seborrheic dermatitis of the scalp.
AuthorsMark Lebwohl, Todd Plott
JournalInternational journal of dermatology (Int J Dermatol) Vol. 43 Suppl 1 Pg. 17-20 (Jul 2004) ISSN: 0011-9059 [Print] United States
PMID15271196 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Antifungal Agents
  • Hair Preparations
  • Pyridones
  • ciclopirox
  • Administration, Cutaneous
  • Antifungal Agents (administration & dosage)
  • Dermatitis, Seborrheic (drug therapy)
  • Double-Blind Method
  • Female
  • Hair Preparations
  • Humans
  • Male
  • Pyridones (administration & dosage)
  • Scalp Dermatoses (drug therapy)
  • Treatment Outcome
  • United States

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