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 who are 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 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. Diabetics 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 |
|---|---|
| Main Objective: The objective of the first part of this study is to determine the human skin irritation potential of 0.25%, 0.5%, 1.0% and 1.5% w/w Ciclopirox Olamine (CPO) Solution following cutaneous patch applications, to determine the acceptable concentrations to be used in Part 2 of the study. The primary objective of the second part of this study is to confirm that the CPO solution does not cause contact sensitisation under the conditions of this study. The secondary objective is to evaluate the cumulative irritation potential of the CPO solution during the induction phase. ;Secondary Objective: ;Primary end point(s): The primary endpoint will be the percentage of subjects with reactions indicative of contact sensitisation, occurring at challenge phase. Wilcoxon Signed Rank tests will be employed to determine a difference between the induction and the challenge scores, to determine whether the subjects have been sensitised at Day 3 and 5 time-points. A new variable, which will take the value of 1 if the subject has become sensitised and 0 if not, will also be created. Wilcoxon Signed Rank tests will be performed on this new variable as the outcome variable to determine whether there is any difference between the numbers of subjects who have become sensitised to the 2 products. A narrative description of reactions in the challenge phase will also be provided, together with the opinion of the Investigator as to whether such reactions are felt to be indicative of contact sensitisation. | — |
Countries
United Kingdom
Outcome results
None listed