CompletedNCT00731042Updated Dec 2, 2024Results posted

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

A Phase 4 interventional study of Avagard and Purell Surgical Scrub in Healthy, sponsored by Solventum US LLC. Completed. Open to female participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Solventum US LLC · Phase 4, Interventional, and Other

Phase: Phase 4
Study type: Interventional
Enrollment: 33
Allocation: Randomized
Ages: 25 Years to 55 Years
Sex: Female

Study summary

Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

Conditions studied

Healthy

Browse trials for

Skin Diseases 538

Keywords

Skin health

In context

Skin Diseases

538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.

This study's enrollment of 33 is below the median of 60 across 372 interventional studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

Solventum US LLC is the lead sponsor of 62 studies on the registry; 2 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 55 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 4
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 33 participants (actual)

Study arms

Experimental
Avagard
3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers
Drug: Avagard
Active comparator
Purell
Purell Surgical Scrub with Moisturizers
Drug: Purell Surgical Scrub

Interventions

DrugAvagard
Topical solution, 6 mL, 6 applications/day for 14 days.
DrugPurell Surgical Scrub
Topical solution, 4 mL, 6 applications/day for 14 days.
Also known as: Purell Surgical Scrub with Moisturizers

What researchers measure

Primary outcomes

Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days
Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).
Time frame: Baseline and 14 days

Results

Posted Jun 17, 2009

Participant flow

First Intervention

Participant flow — First Intervention
Milestone	Purell First Followed by Avagard	Avagard First Followed by Purell
Started	16	17
Completed	16	17
Not completed	0	0

Wash-out

Participant flow — Wash-out
Milestone	Purell First Followed by Avagard	Avagard First Followed by Purell
Started	16	17
Completed	16	17
Not completed	0	0

Second Intervention

Participant flow — Second Intervention
Milestone	Purell First Followed by Avagard	Avagard First Followed by Purell
Started	16	17
Completed	16	15
Not completed	0	2
Withdrew: Did not meet inclusion criteria	0	2

Outcome measures

PrimaryChange From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days

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

Time frame:: Baseline and 14 days
Reported as:: Mean · units on a scale

Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days
units on a scale	Purell First Followed by Avagard	Avagard First Followed by Purell
Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days	0.1 ± 1.11	0.4 ± 1.53

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Purell First Followed by Avagard	—	0/16 (0%)	0/16 (0%)
Avagard First Followed by Purell	—	0/17 (0%)	0/17 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Purell First Followed by Avagard	Avagard First Followed by Purell	Total
<=18 years	0	0	0
Between 18 and 65 years	16	17	33
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Purell First Followed by Avagard	Avagard First Followed by Purell	Total
Female	16	17	33
Male	0	0	0

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00731042
Lead sponsor: Solventum US LLC
Collaborators: 3M
Responsible party: Sponsor
First posted: Aug 8, 2008
Start date: Mar 2008
Primary completion: Apr 2008
Completion: Jul 2008
Results posted: Jun 17, 2009
Last update: Dec 2, 2024

Study contacts

Gary L Grove, PhD

principal investigator · cyberDERM Clinical Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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