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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731042
• Other study ID #: I2MS05-010877
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2008
• Last updated: January 24, 2012
• Start date: March 2008
• Est. completion date: July 2008

Study information

• Verified date: January 2012
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy
• Skin Diseases

Intervention

Drug:
• Avagard
Topical solution, 6 mL, 6 applications/day for 14 days.
• Purell Surgical Scrub
Topical solution, 4 mL, 6 applications/day for 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
3M

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days	Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).	Baseline and 14 days	No