None listed
Conditions
Interventions
Intervention1: Octenidine Dihydrochloride 0.3% Hand & Body Wash Gel: Octenidine Dihydrochloride 0.3% Hand & Body Wash Gel for external use. Dosages of drug: 2 X 3ml over 60 seconds.
Control Interventi
Sponsors
Dishman Pharmaceuticals Chemicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: I. Healthy male & female volunteers between 18 to 65 years of age. II. Volunteers must possess both hands. III. Volunteers must be free of dermatoses, cuts, lesions, hangnails, or other skin disorders on hands and forearms. IV. 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. V. Volunteers must be in good health. VI. Volunteers must have read and signed the Informed Consent Form. VII. Volunteers should not have any past medical history of sensitivity to the use of such products. VIII. Should not have known sensitivity to the treatment constituents. IX. Volunteers should be able to read, write and understand English language.
Exclusion criteria
Exclusion criteria: I. A current skin disease of any type (e.g. eczema, psoriasis). II. Cuts, abrasions or open wounds on the hands. III. Known sensitivity to the treatment constituents. IV. 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. V. 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. VI. Use of systemic or topical antibiotic medications during the seven days pre- test period or on the single test day. VII. Known allergies to Octenidine Dihydrochloride Compounds or any of the ingredients of test and reference formulations. VIII. Pregnancy plans to become pregnant within the seven days pre-test and test periods of the study or nursing a child. IX. Any active skin rashes or breaks in the skin of hands or forearms. X. A currently active skin disease or inflammatory skin condition, including contact dermatitis. XI. Pregnant or lactating female volunteer. XII. Participation in a clinical study in the past thirty days or current participation in another clinical trial. XIII. Unwillingness to fulfill the performance requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate and compare the antimicrobial effectiveness of a Octenidine Dihydrochloride 0.3% Hand & Body Wash Gel Vs. propanol-2-ol (60%) disinfectant solution when used for hygienic handwash purpose.Timepoint: â?¢ To evaluate and compare the antimicrobial effectiveness of a Octenidine Dihydrochloride 0.3% Hand & Body Wash Gel Vs. propanol-2-ol (60%) disinfectant solution when used for hygienic handwash purpose. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To determine the tolerability of Octenidine Dihydrochloride 0.3% Hand & Body Wash Gel.Timepoint: All SAEâ??s occurring during the study must be reported to the sponsor by telephone or fax within 24 hours of the investigator becoming aware of the SAE. | — |
Countries
India
Contacts
Public ContactDr Bula Aruna MD Microbiology
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital
Outcome results
None listed