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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Purell Surgical Scrub; Drug: Avagard

• Registration Number: NCT00731042
• Lead Sponsor: Solventum US LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-04
• Study Completion: 2008-07
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Results First Submitted: 2009-01-23
• Results First Submitted QC: 2009-06-16
• Results First Posted: 2009-06-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Purell	Purell Surgical Scrub	Purell Surgical Scrub with Moisturizers
Avagard	Avagard	3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days	Baseline and 14 days	Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).