ocal antibacterial efficacy of a gel containing 0.1 % octenidine dihydrochloride on pre-damaged skin - Local antibacterial efficacy of octenidine dihydrochloride

• Conditions: healthy volunteersantiseptic for repeated, temporarily limited antiseptic treatment of superficial skin injuries

• Registration Number: EUCTR2010-024572-25-DE
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-17
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

•Medication

-Systemic treatment with drugs interfering with the immune system (see table below):

Corticosteroids, antibiotics30 days prior to study day 1 and during conduct of study
Immunosuppressants30 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, antibiotics2 weeks prior to study day 1 and during conduct of study
Anti-inflammatory substances2 weeks prior to study day 1 and during conduct of study
Pretreatment with any of the test preparations tested in this study30 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-phase14 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified