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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731042
First Posted: August 8, 2008
Last Update Posted: January 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
3M
  Purpose
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

Condition Intervention Phase
Healthy Drug: Avagard Drug: Purell Surgical Scrub Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days [ Time Frame: 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).


Enrollment: 33
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avagard
3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers
Drug: Avagard
Topical solution, 6 mL, 6 applications/day for 14 days.
Active Comparator: Purell
Purell Surgical Scrub with Moisturizers
Drug: Purell Surgical Scrub
Topical solution, 4 mL, 6 applications/day for 14 days.
Other Name: Purell Surgical Scrub with Moisturizers

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731042


Sponsors and Collaborators
3M
Investigators
Principal Investigator: Gary L Grove, PhD cyberDERM Clinical Research
  More Information

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00731042     History of Changes
Other Study ID Numbers: I2MS05-010877
First Submitted: August 6, 2008
First Posted: August 8, 2008
Results First Submitted: January 23, 2009
Results First Posted: June 17, 2009
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by 3M:
Skin health

Additional relevant MeSH terms:
Skin Diseases
Anti-Infective Agents, Local
Chlorhexidine gluconate
Chlorhexidine
Hand Sanitizers
Anti-Infective Agents
Disinfectants
Dermatologic Agents