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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014