Seborrhoeic dermatitis MedDRA version: 8.1 Level: LLT Classification code 10039793 Term: Seborrhoeic dermatitis
Conditions
Interventions
Product Name: CPO 1.5% Solution
Product Code: S241
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Ciclopirox
CAS Number: 41621-49-2
Current Sponsor code: S241
Other descriptive name: Cic
Sponsors
Stiefel Laboratories Maidenhead Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed. 2. Male or female. 3. Aged 16 years and above at time of consent. 4. Confirmed as having seborrhoeic dermatitis of the scalp, with a traceable area of seborrhoeic dermatitis, as assessed by a consultant dermatologist. 5. Willing to wash their hair 3 times a week (every other day) for the duration of the study using the bland shampoo and conditioner provided. 6. Overall dandruff severity score of 6 or over at baseline. 7. Able to follow the instructions for application of the test product and able to apply the test product directly to the scalp. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute, weeping or infected dermatoses on the scalp, face or ears. 2. History of known or suspected intolerance to any of the ingredients of the investigational medicinal product. 3. Received any unlicensed drug within 30 days of screening visit or who are scheduled to receive an investigative drug other than the study medication during the period of the study. 4. Systemic diseases that, in the opinion of the Investigator, may adversely influence their participation in the trial. 5. Female subjects who are pregnant or lactating. 6. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered as a medically acceptable form of contraception. 7. Considered unable or unlikely to attend the necessary visits. 8. Used oral steroids or topical steroids on the scalp within 30 days of screening visit. 9. Used any medicinal product (i.e. other than a cosmetic/toiletry anti-dandruff shampoo) for their scalp condition within 30 days of screening visit. 10. Known human immunodeficiency virus (HIV) positive status. 11. Psoriasis, eczema or any other condition affecting the scalp, face or ears, except for seborrhoeic dermatitis. 12. Employees of Chiltern International Limited or Stiefel International R&D, 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 efficacy of three concentrations of CPO solution and placebo solution in the treatment of seborrhoeic dermatitis of the scalp.;Secondary Objective: To assess the safety and tolerability of three concentrations of CPO solution and placebo solution in the treatment of seborrhoeic dermatitis of the scalp.;Primary end point(s): The change in area of seborrhoeic dermatitis on the scalp from day 1 to day 29 (start to end of treatment). | — |
Countries
United Kingdom
Outcome results
None listed