Healthy volunteers
Conditions
Interventions
Trade Name: Bétadine® Alcoolique 5%
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: povidone-iodine
CAS Number: 25655-41-8
Current Sponsor code: X-00069
Other descriptive name: POVIDONE-
Sponsors
Meda Pharma GmbH & Co. KG (A Mylan company)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and/or female subjects aged between 18 and 65 years (inclusive). 2. An informed consent form signed and dated by the subject. 3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4. Subjects having a BMI less than or equal to 30. 5. Subjects having adequate back size to cover 4 application fields of 10 x10 cm with at least 6 cm in between. 6. Subject having a minimum CFU count of 2.5 log10/cm2 screening visit. 7. Subject affiliated to a health social security system. 8. Females of childbearing potential, willing to use acceptable methods of contraception 1 month before validation or before screening and during the study participation period. 9. Males with a female partner being in childbearing potential, willing to use themselves or to have their partner use an acceptable method of contraception 1 month before validation or before screening and during the study participation period. Are the trial subjects under 18? no 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions to povidone or to iodine or to any of the excipients of the IMP. 2. Subjects with pre-existing thyroid disorders 3. History of renal failure or pre-existing renal failure disorder. 4. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol within 1 month before study beginning and during validation and the main study. 5. Male subjects, whose female partner is pregnant. 6. Subjects who went to the swimming pool or spa within 14 days before IMP application / validation. 7. History of regular alcohol consumption exceeding 21 units/week (1 unit = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of validation / screening or tobacco smoking of more than 10 cigarettes per day or consuming drugs. 8. Intensive exposure to sunlight or UV-rays on the studied zone (sunburn) within the previous month before validation / screening and / or foreseen during the study. 9. Subjects having scars, large burns, and lesions on the skin of the back that can have an impact on the evaluations. 10. Subjects taking a systemic antibiotic or corticoid treatment, or a topical antiseptic treatment on the back as well as a local treatment that can influence the evaluation at the Investigator’s discretion within 14 days before validation / screening and / or foreseen during the study. 11. Subjects using cosmetics (including sun cream) on the back or using antiseptic shampoo or shower gel within 14 days before validation / IMP application. 12. Subjects with a condition or receiving a medication which, in the investigator’s judgment, put the subject at undue risk or may interfere with the evaluation of the study results. 13. Subjects suffering from a severe or evolutive disease (including renal insufficiency, Diabetes, HIV or subject being otherwise immune-compromised). 14. Subjects with dermatological diseases at the Investigator’s discretion. 15. Subject undergoing a medical topical treatment on the test area (back) within 14 days before validation / screening or planned during the study. 16. Subjects having a shower /bath within 48 hours before validation / screening or before treatment visit 17. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol and ICF. 18. Vulnerable Subjects (such as persons kept in detention). 19. Exposure to an oral investigational product or a topical investigational product on the back within the last three months before screening. 20. Subjects currently enrolled in another clinical trial for which the study participation period or exclusion period is not completed. 21. Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to evaluate the antiseptic activity of a 5% alcoholic povidone-iodine solution (Bétadine® Alcoolique 5%) applied with 4 different modes of application;Secondary Objective: Not applicable;Primary end point(s): Antiseptic activity of alcoholic povidone-iodine 5% solution will be assessed by measuring the change from baseline in log10 CFU counts for total aerobic and facultative anaerobic bacteria using 4 different modes of application.;Timepoint(s) of evaluation of this end point: After a single application (using 4 different modes of application) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the safety of 5% alcoholic povidone-iodine solution (Bétadine® Alcoolique 5%) applied with 4 different modes of application.;Timepoint(s) of evaluation of this end point: After a single application (using 4 different modes of application) | — |
Countries
France
Contacts
Public ContactClinical Affairs GKB
Meda Pharma GmbH & Co. KG (A Mylan company)
Outcome results
None listed