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. 2015 Apr 29;(4):CD008138. doi: 10.1002/14651858.CD008138.pub2

EUCTR2005-001371-35

Trial name or title A Double-Blind, Placebo-Controlled, Half-Head Design, CPO Solution Dose Ranging-Finding Study in Patients With Seborrhoeic Dermatitis of the Scalp
Methods Randomised double-blind parallel-group trial
Participants Diagnosis: male or female participant aged 16 years and older with seborrhoeic dermatitis of the scalp with minimum visual scaling score of 5, differing between bilateral study sites by a score of no more than 17, will be willing to have their hair washed only 3 or 4 times during the treatment phase of the study - and always at the study site - and who will be willing to have a small section of hair clipped to enable removal of scales for yeast samplingExclusion criteria: patients with acute weeping or infected scalp dermatoses, patients with a history of known intolerance to any of the investigational products, patients who have received any unlicensed drug within the previous 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study, patients with systemic diseases that may adversely influence their participation in the trial, female patients who are pregnant or lactating and many others
Interventions Intervention: ciclopirox olamine 1.5% solution applied to scalp for 4 weeks
Control:
  • Ciclopirox olamine 1% solution applied to scalp for 4 weeks

  • Ciclopirox olamine 0.5% solution applied to scalp for 4 weeks

  • Placebo solution applied to scalp for 4 weeks

Outcomes "The primary end point will be the change in area of seborrhoeic dermatitis from day 01 to day 29"
Starting date 18-05-2005
Contact information euctr@ema.europa.eu euctr@ema.europa.eu
Notes Country: United Kingdom. We were not able to trace whether the trial has been published