A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects

Solventum US LLC0 sites33 target enrollmentMarch 2008

ConditionsHealthy

Overview

Phase: Phase 4
Intervention: Avagard
Conditions: Healthy
Sponsor: Solventum US LLC
Enrollment: 33
Primary Endpoint: Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days
Status: Completed
Last Updated: last year

Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

July 2008

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

Female

Sponsor

Responsible Party

Sponsor

•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

•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