A single center, open label study to evaluate the antimicrobial efficacy of Octenidine Dihydrochloride 0.3% Hand & Body Wash Gel as per CEN 1499 Standard on healthy volunteers

Phase 3

Completed

• Registration Number: CTRI/2015/05/005816
• Lead Sponsor: Dishman Pharmaceuticals Chemicals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified