healthy volunteers antiseptic for repeated, temporarily limited antiseptic treatment of superficial skin injuries
Conditions
Interventions
Product Name: Octenidine wound gel
Product Code: WO 2612
Pharmaceutical Form: Gel
INN or Proposed INN: OCTENIDINE DIHYDROCHLORIDE
CAS Number: 70775756
Concentration unit: % (W/W) percent weight/weight
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Caucasian men and women (skin type I to IV, Fitzpatrick et al. 1974) •Age 18 to 70 •Healthy skin at the test areas •Willingness to actively participate in the study and to come to the scheduled visits •Willingness to adhere to the study procedures including wash-out phase •Signed written informed consent to participate in the study •Negative urine pregnancy test (in female subjects of child bearing potential) •Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Medication -Systemic treatment with drugs interfering with the immune system (see table below): Corticosteroids, antibiotics 30 days prior to study day 1 and during conduct of study Immunosuppressants 30 days prior to study day 1 and during conduct of study Antiphlogistics (minor pain relief medicine like acetylsalicylic acid or acetaminophene if not more than 1000 mg per day is allowed) 30 days prior to study day 1 and during conduct of study Regular intake of blood-thinning products such as Marcumar and acetylsalicylic acid -Topical treatment of test areas (see table below): Corticosteroids, antibiotics 2 weeks prior to study day 1 and during conduct of study Anti-inflammatory substances 2 weeks prior to study day 1 and during conduct of study Pretreatment with any of the test preparations tested in this study 30 days prior to study day 1 and during conduct of study Application of any products, other than the provided cleaning product, at the forearms such as moisturizers, perfumes, disinfection during washout-phase 14 days prior study day 1 and during conduct of study Diseases Atopic dermatitis, eczema, and/or sensitive, very dry skin Psoriasis and lichen ruber Active skin disease, e.g. skin tumors Moderate or severe illness within the last two weeks before first exposure Known infectious diseases (e.g. hepatitis or AIDS) Insulin-dependent Diabetes •Known hypersensitivity against the test products, to ingredients of the test products, to products of similar chemical classes or to plaster •Pregnancy or lactation •Moles, tattoos, pigmentation or scars on the forearm that would influence the visual scoring •Hairy forearms •Intensive UV-light exposure within two weeks before the beginning of the test as well as during the study •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing •Any history of drug addiction or alcoholism in the past 3 years •Subjects with poor compliance •Subjects, who are inmates of psychiatric wards, prison or state institutions •Participation in a clinical trial within the last 30 days prior to the start of this study •Subjects underlying any other restrictions due to the participation in other tests / test institutes •Employees of the study sites or of the Sponsor’s company •If in the opinion of the investigator the subject should not participate in the study for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is a significant reduction of total bacterial count after 3h, 6h and 1h of application compared to placebo.;Secondary Objective: •Significant reduction of total bacterial count after 1h, 3h and 6h of application compared to untreated. •Safety parameters (including skin tolerability, assessment of burning/itching and erythema) are documented and analyzed ;Primary end point(s): Comparison of test product with placebo at t1, t2 and t3 on log-transformed reductions to initial bacterial load for quantitative bacteriological results | — |
Countries
Germany
Outcome results
None listed