Not Applicable (Healthy Volunteer Study)
Conditions
Interventions
Product Name: CPO 1.5% Solution
Product Code: Not Applicable
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Ciclopirox
CAS
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) no 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 to the patch material. 6. Have received an investigational medicinal product or participated in any other test during the past 30 days 7. Concurrent participation in any other research study 8. Presence of irritated skin, tattoos, moles etc. on the test sites at screening 9. Employee of Sequani Clinical or Steifel 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: The primary objective of this study is to assess the primary skin irritation potential of CPO at three different concentrations of CPO (1.5%w/w, 1.0%w/w and 0.5%w/w), compared to Placebo Solution and Sterile Water.;Secondary Objective: ;Primary end point(s): The endpoint will be the mean primary irritation scores calculated from the individual gradings recorded by the assessor. | — |
Countries
United Kingdom
Outcome results
None listed