Phase 4
N=33
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00731042 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcome: Primary: Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days — 0.1; 0.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Avagard (Drug); Purell Surgical Scrub (Drug)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Solventum US LLC
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days |
0.1; 0.4 | — |
Summary
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00731042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.