Official Title
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
Phase
Phase 4Lead Sponsor
3MStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HealthyIntervention/Treatment
ethanol chlorhexidine ...Study Participants
33Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.
Topical solution, 6 mL, 6 applications/day for 14 days.
Topical solution, 4 mL, 6 applications/day for 14 days.
3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers
Inclusion Criteria: Female age 25 - 55 Subject agrees not to use any hand wash products on their hands other than what has been provided in the study. Subject agrees not to use any moisturizers or any skin products on their hands during the study Subject agrees to use gloves to protect hands from activities such as dish washing Subject is willing to sign the Informed Consent and HIPAA Subject agrees to comply with the study requirement Exclusion Criteria: Subject has a history of psoriasis, active dermatitis, skin reactions, cracked, irritated, broken skin, skin infection on their hands Subject has scaly skin on hands based on Visual Scoring Scale at Day 1 Subject has a sensitivity or history of skin reactions to any study materials (eg, alcohol, chlorhexidine gluconate or zinc pyrithone or latex in the gloves) Subject has been using moisturizing products or any products on their arms and hands within 5 days prior to participation in the study Subject is pregnant Study coordinator believes the subject is unsuitable for inclusion in the study
| Event Type | Organ System | Event Term |
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Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).
