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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT00731042
First received: August 6, 2008
Last updated: January 24, 2012
Last verified: January 2012

August 6, 2008
January 24, 2012
March 2008
April 2008   (final data collection date for primary outcome measure)
Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]
Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).
skin health [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00731042 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Healthy
  • Drug: Avagard
    Topical solution, 6 mL, 6 applications/day for 14 days.
  • Drug: Purell Surgical Scrub
    Topical solution, 4 mL, 6 applications/day for 14 days.
    Other Name: Purell Surgical Scrub with Moisturizers
  • Experimental: Avagard
    3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers
    Intervention: Drug: Avagard
  • Active Comparator: Purell
    Purell Surgical Scrub with Moisturizers
    Intervention: Drug: Purell Surgical Scrub
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
July 2008
April 2008   (final data collection date for primary outcome measure)

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
Female
25 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00731042
I2MS05-010877
No
3M
3M
Not Provided
Principal Investigator: Gary L Grove, PhD cyberDERM Clinical Research
3M
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP