Seborrhoeic dermatitis MedDRA version: 8.0 Level: LLT Classification code 10039793
Conditions
Interventions
Product Name: CPO 1.5% Solution
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Ciclopirox
CAS Number: 41621-49-2
Other descriptive name: Ciclopirox olamine
Concentration unit: % (W/W) pe
Sponsors
Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel Laboratories International Division)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provided written Informed Consent 2. Male or female 3. Aged 16 years and above 4. Confirmed as having seborrhoeic dermatitis of the scalp 5. Willing to have their hair washed only 3 or 4 times weekly for the four week treatment phase of the study, and always at the study site 6. Overall scaling/flaking meets a minimum visual scaling score of 5, and differing between the bilateral study sites by a score of no more than 1 7. Willing to have a small section of hair clipped in order to assist in the removal of scales for yeast sampling Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with acute, weeping or infected scalp dermatoses 2. Patients with a history of known or suspected intolerance to any of the ingredients of the investigaional product 3. Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study 4. Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial 5. Female patients who are pregnant or lactating 6. Patients considered unable or unlikely to attend the necessary follow-up visits 7. Patients who have used oral steriods, or topical steriods on the scalp, within the previous 4 weeks 8. Patients who have used any medicinal product (i.e. other than a cosmetic/toiletry anti-dandruff shampoo) for their scalp condition within the previous 4 weeks 9. Employee of Sequani Clinical of Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effectiveness of three concentrations of CPO Solution (0.5%w/w, 1.0%w/w, 1.5%w/w) and placebo solution in the treatment of seborrhoeic dermatitis.;Secondary Objective: Not applicable;Primary end point(s): The primary end point will be the change in area of seborrhoeic dermatitis from day 01 to day 29. | — |
Countries
United Kingdom
Outcome results
None listed