Trial Outcomes & Findings for A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects (NCT NCT00731042)

NCT ID: NCT00731042

Last Updated: 2024-12-02

Results Overview

Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline and 14 days
• Results posted on: 2024-12-02

Participant Flow

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.

Participant milestones

Measure	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.
First Intervention STARTED	16	17
First Intervention COMPLETED	16	17
First Intervention NOT COMPLETED	0	0
Wash-out STARTED	16	17
Wash-out COMPLETED	16	17
Wash-out NOT COMPLETED	0	0
Second Intervention STARTED	16	17
Second Intervention COMPLETED	16	15
Second Intervention NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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.
Second Intervention Did not meet inclusion criteria	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Purell First Followed by Avagard n=16 Participants Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.	Avagard First Followed by Purell n=17 Participants Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 14 days

Population: Analysis was done per protocol

Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).

Outcome measures

Measure	Purell First Followed by Avagard n=15 Participants Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.	Avagard First Followed by Purell n=15 Participants Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days	0.1 units on a scale Standard Deviation 1.11	0.4 units on a scale Standard Deviation 1.53

Adverse Events

Purell First Followed by Avagard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Avagard First Followed by Purell

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chou Eyberg

3M Company

Phone: 651-737-0934

Email: cieyberg1@mmm.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI was a test lab, and they do not publish study result. Sponsor can choose to publish.
• Publication restrictions are in place

Restriction type: OTHER