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
Results First Received: January 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Outcomes Assessor)
Condition: Healthy
Interventions: Drug: Avagard
Drug: Purell Surgical Scrub

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After screening, there was a 5-days washout prior to enrollment into period 1. This was then followed by another 5-days washout between periods 1 and 2.

Reporting Groups
  Description
Purell First Followed by Avagard Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
Avagard First Followed by Purell Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.

Participant Flow for 3 periods

Period 1:   First Intervention
    Purell First Followed by Avagard     Avagard First Followed by Purell  
STARTED     16     17  
COMPLETED     16     17  
NOT COMPLETED     0     0  

Period 2:   Wash-out
    Purell First Followed by Avagard     Avagard First Followed by Purell  
STARTED     16     17  
COMPLETED     16     17  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Purell First Followed by Avagard     Avagard First Followed by Purell  
STARTED     16     17  
COMPLETED     16     15 [1]
NOT COMPLETED     0     2  
Did not meet inclusion criteria                 0                 2  
[1] 2 subjects did not met inclusion criteria for Period 2 Visual scoring skin condition



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Purell First Followed by Avagard Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
Avagard First Followed by Purell Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
Total Total of all reporting groups

Baseline Measures
    Purell First Followed by Avagard     Avagard First Followed by Purell     Total  
Number of Participants  
[units: participants]
  16     17     33  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     17     33  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     16     17     33  
Male     0     0     0  



  Outcome Measures

1.  Primary:   Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days   [ Time Frame: Baseline and 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chou Eyberg
Organization: 3M Company
phone: 651-737-0934
e-mail: cieyberg1@mmm.com


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