None listed
Conditions
Interventions
Intervention1: Trimethoxysilyl Quaternary Ammonium Chloride: Trimethoxysilyl Quaternary Ammonium Chloride 0.4%
Hand protectant and sanitizer for external use.
Dosages of drug: 2 X 3ml over 60 seconds.
Sponsors
PUREERA INDIA Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a)Healthy male & female volunteers between 18 to 65 years of age. b)Volunteers must possess both hands. c)Volunteers must be free of dermatoses, cuts, lesions, hangnails, or other skin disorders on hands and forearms. d)Volunteers must not have used topical or systemic antimicrobials, antibiotics, or steroids for the one week pre-test and must agree to abstain from these materials until the completion of the study. e)Volunteers must be in good health. f) Volunteers must have read and signed the Informed Consent Form. g)Volunteers should not have any past medical history of sensitivity to the use of such products. h)Should not have known sensitivity to the treatment constituents.
Exclusion criteria
Exclusion criteria: a)>= 65 years. b) c)Pregnancy or lactation d)A current skin disease of any type (e.g. eczema, psoriasis). e)Cuts, abrasions or open wounds on the hands. f)Known sensitivity to the treatment constituents. g)Exposure of ungloved hands and forearms to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions or use of biocide-treated pools or hot tubs during the seven days pre-test or on the single test day. h)Exposure or ungloved hands or forearms to strong detergents, solvents or other irritants during the seven days pre-test or on the single test day. i)Use of systemic or topical antibiotic medications during the seven days pre- test period or on the single test day. j)Known allergies to Trimethoxysilyl Quaternary Ammonium Compounds or any of the ingredients of test and reference formulations. k)Pregnancy plans to become pregnant within the seven days pre-test and test periods of the study or nursing a child. l)Any active skin rashes or breaks in the skin of hands or forearms. m)A currently active skin disease or inflammatory skin condition, including contact dermatitis. n)Participation in a clinical study in the past thirty days or current participation in another clinical trial. o)Unwillingness to fulfill the performance requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the antimicrobial effectiveness of hygienic handrub product by comparing it with a reference handrub propan-2-ol 60% (v/v) solution in order to validate its suitability as a hygienic handrub.Timepoint: 60 seconds post application of handrub hands are checked for bacterial count. For the hygienic handrub product to be considered suitable, when tested in accordance with EN 1500 standard, the mean reduction of the release of test organisms achieved by the hygienic handrub product shall not be significantly smaller than that achieved by a reference handrub (R) with propan-2-ol 60 % (V/V). | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Manorama Deb
VMMC and Safdarjung Hospital
Outcome results
None listed