Not applicable (Healthy Volunteer Study)
Conditions
Interventions
Product Name: CPO 1.5% Leave-on Solution
Pharmaceutical Form: Cutaneous solution
Pharmaceutical form of the placebo: Cutaneous solution
Route of administration of the placebo: Cutaneous use
Product N
Sponsors
Stiefel Laboratories International Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male of 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) 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 of topical steriods 4. Use of any topical or systemic medication, immunisations, anti-inflammatory, immunosuppressive or anti-histamine drugs likely to interfere with the study 5. History of skin disease or allergy likely to interfere with the study or known sensitivity to the test products of their ingredients 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 study on the test sites at screeening 9. Employee of Sequani Clinical or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or siblings 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 Leave-on Solution at three different concentrations of CPO (0.5% w/w, 1.0% w/w & 1.5% w/w), compared to Placebo Solution (vehicle), three marketed comparators: Batrafen Solution (CPO 1% w/w), Mycoster Solution (CPO 1% w/w), Dovonex Scalp Solution (Calcipotriol 0.005%) 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