Not Applicable (Healthy Volunteer Study)
Conditions
Sponsors
Stiefel Laboratories Maidenhead Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers, of either sex, aged 16 or over. 2. Completed 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. Female subjects who are pregnant or lactating. 2. Sexually active women of childbearing potential participating in the study not using 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. 3. Participation in a patch test or repeat insult patch test during the previous 12 weeks. 4. Participation in any other research study on the same skin site during the previous 4 weeks. 5. Concurrent participation in any other research study. 6. Presence of irritated skin, tattoos, scars or birthmarks at the test site at screening. 7. Any significant concurrent illness. 8. Use of oral or topical steroids. 9. 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. 10. Subjects considered unable or unlikely to attend the necessary visits. 11. Employees of 4-Front Research UK Ltd or Stiefel International R&D, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee. 12. Concurrent medication likely to affect the response to the test products or confuse the results of the study i.e. routine high dosage use of anti-inflammatory drugs, (such as aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamine medication. 13. Known or suspected sensitivity to the treatment solutions/products or their constituents including patch materials. 14. Heavy alcohol consumption in the opinion of the Investigator (more than 14 units per week for women or 21 units for men). 15. A fever in the 12 hours prior to the first patch application. 16. Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the volunteer or affect the outcome of the study. 17. History of malignant disease. 18. Diabetes. 19. Recent immunisation (less than 10 days prior to test patch application). 20. Use of self tanning lotion on the test area (arm), one week previous to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): The endpoint will be the mean primary irritation scores calculated from the individual grading recorded by the assessor.;Main Objective: The objective of this study is to determine the primary skin irritation potential of Ciclopirox Olamine (CPO) at three different concentrations (1.5%w/w, 1.0%w/w and 0.5%w/w) compared against three comparator products, water (sterile water) and a Placebo (vehicle with no CPO) following cutaneous patch applications. The water and placebo, along with a blank patch will be used as controls. | — |
Countries
United Kingdom
Outcome results
None listed