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
  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 Blind (Subject, 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 ] [ 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).


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

Ages Eligible for Study:   25 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731042

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

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00731042     History of Changes
Other Study ID Numbers: I2MS05-010877
Study First Received: August 6, 2008
Results First Received: January 23, 2009
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 3M:
Skin health

Additional relevant MeSH terms:
Skin Diseases
Ethanol
Anti-Infective Agents, Local
Chlorhexidine gluconate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 15, 2014