Not Applicable (Healthy Volunteer Study)
Conditions
Interventions
Product Name: CPO 1.5% Leave-on Solution
Product Code: Not Applicable
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Ciclopirox
CAS Number: 41621-49-2
Other descriptive name: Ciclopirox
Sponsors
Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel International R&D)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Aged 16-65 years 3. Willing and able to provide written informed consent 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. Females who are pregnant, breast-feeding or of child bearing potential who are not using a medically approved form of contraception 2. Any significant concurrent illness 3. Use of oral or topical steroids 4. Use of any prohibited medications as listed in section 3.6.2 5. History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients or the patch material (Webril®/Blenderm®) 6. Participation in a repeat insult patch test during the previous 12 weeks 7. Participation in any other research study on the same skin site during the previous 4 weeks 8. Participation in any patch test involving the same skin site in the last 4 to 12 weeks where the skin irritation reactions have not yet completely cleared 9. Concurrent participation in any other research study 10. Presence of irritated skin, tattoos, scars or birthmarks at the test site at screening 11. Employee of Sequani Clinical or 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 contact sensitisation potential of CPO 1.5%w/w Leave-On Solution;Secondary Objective: To determine the skin irritation potential of CPO 1.5%w/w Leave-On Solution ;Primary end point(s): The endpoint will be the percentage of subjects with reactions indicative of contact sensitisation occurring at challenge of the original and alternative skin sites. | — |
Countries
United Kingdom
Outcome results
None listed