HealthyPhase 4NCT00731042
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
A Phase 4 study testing Avagard and Purell Surgical Scrub in people with Healthy, run by Solventum US LLC.
Trial summary
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Avagard and Purell Surgical Scrub
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.
- Conditions
- Healthy
- Being tested
- Avagard, Purell Surgical Scrub
- Keywords
- Skin health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvagardDrug
Topical solution, 6 mL, 6 applications/day for 14 days.
Purell Surgical ScrubDrug
Also called Purell Surgical Scrub with Moisturizers
Topical solution, 4 mL, 6 applications/day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Avagard | Experimental | 3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers Receives: Drug: Avagard |
| Purell | Active comparator | Purell Surgical Scrub with Moisturizers Receives: Drug: Purell Surgical Scrub |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Gary L Grove, PhD, Principal investigator, cyberDERM Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731042
- Sponsor's protocol ID
- I2MS05-010877
- Status last verified
- Nov 2024
- First submitted
- 6 Aug 2008
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT00731042
- Acronym / sponsor ID
- I2MS05-010877
- Conditions
- Healthy
- Keywords
- Skin health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 17 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avagard | Experimental | Drug: Avagard3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers |
| Purell | Active comparator | Drug: Purell Surgical ScrubPurell Surgical Scrub with Moisturizers |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvagardTopical solution, 6 mL, 6 applications/day for 14 days. | Drug | Avagard |
| Purell Surgical ScrubAlso: Purell Surgical Scrub with MoisturizersTopical solution, 4 mL, 6 applications/day for 14 days. | Drug | Purell |
Primary outcome
Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days
Time frame: Baseline and 14 days
Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary L Grove, PhD principal investigator
cyberDERM Clinical Research
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avagard and Purell Surgical Scrub in people with Healthy, run by Solventum US LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days (time frame: Baseline and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.