EUCTR2019-000694-24-FRActive, not recruitingPhase 1
Evaluation of the antiseptic activity of 4 different modes of application of a 5% alcoholic povidone-iodine product (Bétadine® Alcoolique 5%)
Meda Pharma GmbH & Co. KG (A Mylan company)0 sites52 target enrollmentStarted: June 28, 2019Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 52
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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