Healthy
Conditions
Keywords
Skin health
Brief summary
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.
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.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days | 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). |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Purell First Followed by Avagard Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days. | 16 |
| Avagard First Followed by Purell Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days. | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention | Did not meet inclusion criteria | 0 | 2 |
Baseline characteristics
| Characteristic | Purell First Followed by Avagard | Avagard First Followed by Purell | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Female | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
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
Population: Analysis was done per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Purell First Followed by Avagard | Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days | 0.1 units on a scale | Standard Deviation 1.11 |
| Avagard First Followed by Purell | Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days | 0.4 units on a scale | Standard Deviation 1.53 |