Bacterial Recovery of Skin Flora Post-product Application
Conditions
Brief summary
Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.
Detailed description
Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.
Interventions
DRUG3M CHG/IPA Prep
Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
DRUGChloraPrep
Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects of any race * Subjects in good health * Minimum skin flora baseline requirements on abdomen and groin
Exclusion criteria
* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area * Topical antimicrobial exposure within 14 days prior to screening and treatment days * Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Skin Flora Recovery Post-prep Application | Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment | The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at 3 defined post-treatment sampling times. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Flora Relative to 10 Minutes Post-prep Application | 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment | Log10 CFU/cm\^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm\^2, at 3 defined post-treatment sampling times. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment | Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderate, 3=severe. |
Participant flow
Pre-assignment details
This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right. Each subject provides 2 abdomen test sites, left or right, and 2 inguen test sites, left or right. Therefore 69 subjects provide 276 potential test sites.
Participants by arm
| Arm | Count |
|---|---|
| 3M CHG/IPA/Abdominal Region Investigational CHG/IPA Prep randomly assigned to the left or right abdominal region test sites | 69 |
| 3M CHG/IPA/Abdominal Region Investigational CHG/IPA Prep randomly assigned to the left or right abdominal region test sites | 69 |
| ChloraPrep/Abdominal Region Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites | 69 |
| ChloraPrep/Abdominal Region Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites | 69 |
| 3M CHG/IPA/Inguinal Region Investigational CHG/IPA Prep randomly assigned to the left or right inguiinal region test sites | 69 |
| 3M CHG/IPA/Inguinal Region Investigational CHG/IPA Prep randomly assigned to the left or right inguiinal region test sites | 69 |
| ChloraPrep/Inguinal Region Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites | 69 |
| ChloraPrep/Inguinal Region Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites | 69 |
| Total | 552 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not meet treatment day baseline | 7 | 7 | 7 | 7 |
Baseline characteristics
| Characteristic | 3M CHG/IPA/Abdominal Region | ChloraPrep/Abdominal Region | 3M CHG/IPA/Inguinal Region | ChloraPrep/Inguinal Region | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 7 Participants | 7 Participants | 7 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 62 Participants | 62 Participants | 62 Participants | 248 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 69 Participants | 69 Participants | 69 Participants | 276 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 69 Participants | 69 Participants | 69 Participants | 276 Participants |
| Sex: Female, Male Female | 48 Participants | 48 Participants | 48 Participants | 48 Participants | 192 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 21 Participants | 21 Participants | 84 Participants |
| Subjects meeting treatment day baseline requirement | 69 test sites on skin | 69 test sites on skin | 69 test sites on skin | 69 test sites on skin | 276 test sites on skin |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 69 | 0 / 69 | 0 / 69 |
| other Total, other adverse events | 0 / 69 | 0 / 69 | 0 / 69 | 0 / 69 |
| serious Total, serious adverse events | 0 / 69 | 0 / 69 | 0 / 69 | 0 / 69 |
Outcome results
Primary
Measurement of Skin Flora Recovery Post-prep Application
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at 3 defined post-treatment sampling times.
Time frame: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment
Population: The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either \> or equal to 3.0 log10 CFU/cm\^2 on the abdomen test site or \> or equal to 5.0 log10 CFU/cm\^2 on the inguinal test site.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Prep - Abdominal Site | Measurement of Skin Flora Recovery Post-prep Application | 96 hour timepoint | 1.21 log10 CFU/cm^2 | Standard Deviation 1.2 |
| Experimental Prep - Abdominal Site | Measurement of Skin Flora Recovery Post-prep Application | 48 hour timepoint | 1.39 log10 CFU/cm^2 | Standard Deviation 1.27 |
| Experimental Prep - Abdominal Site | Measurement of Skin Flora Recovery Post-prep Application | 72 hour timepoint | 0.89 log10 CFU/cm^2 | Standard Deviation 1.11 |
| Active Comparator Prep - Abdominal Site | Measurement of Skin Flora Recovery Post-prep Application | 72 hour timepoint | 0.92 log10 CFU/cm^2 | Standard Deviation 1.05 |
| Active Comparator Prep - Abdominal Site | Measurement of Skin Flora Recovery Post-prep Application | 48 hour timepoint | 1.15 log10 CFU/cm^2 | Standard Deviation 1.02 |
| Active Comparator Prep - Abdominal Site | Measurement of Skin Flora Recovery Post-prep Application | 96 hour timepoint | 1.17 log10 CFU/cm^2 | Standard Deviation 1.18 |
| Experimental Prep - Inguinal Site | Measurement of Skin Flora Recovery Post-prep Application | 72 hour timepoint | 1.94 log10 CFU/cm^2 | Standard Deviation 1.41 |
| Experimental Prep - Inguinal Site | Measurement of Skin Flora Recovery Post-prep Application | 48 hour timepoint | 1.97 log10 CFU/cm^2 | Standard Deviation 1.19 |
| Experimental Prep - Inguinal Site | Measurement of Skin Flora Recovery Post-prep Application | 96 hour timepoint | 2.39 log10 CFU/cm^2 | Standard Deviation 1.48 |
| Active Comparator Prep - Inguinal Site | Measurement of Skin Flora Recovery Post-prep Application | 48 hour timepoint | 1.82 log10 CFU/cm^2 | Standard Deviation 1.1 |
| Active Comparator Prep - Inguinal Site | Measurement of Skin Flora Recovery Post-prep Application | 96 hour timepoint | 2.46 log10 CFU/cm^2 | Standard Deviation 1.52 |
| Active Comparator Prep - Inguinal Site | Measurement of Skin Flora Recovery Post-prep Application | 72 hour timepoint | 2.13 log10 CFU/cm^2 | Standard Deviation 1.3 |
Comparison: 48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment.p-value: 0.1395% CI: [-0.53, 0.07]Paired t-test
Comparison: 72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment.p-value: 0.7895% CI: [-0.23, 0.3]Paired t-test
Comparison: 96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment.p-value: 0.7795% CI: [-0.38, 0.29]Paired t-test
Comparison: 48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment.p-value: 0.3795% CI: [-0.45, 0.17]Paired t-test
Comparison: 72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment.p-value: 0.3395% CI: [-0.2, 0.58]Paired t-test
Comparison: 96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment.p-value: 0.6595% CI: [-0.25, 0.39]Paired t-test
Secondary
Change in Skin Flora Relative to 10 Minutes Post-prep Application
Log10 CFU/cm\^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm\^2, at 3 defined post-treatment sampling times.
Time frame: 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment
Population: The secondary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either \> or equal to 3.0 log10 CFU/cm\^2 on the abdomen test site or 5.0 log10 CFU/cm\^2 on the inguinal test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Prep - Abdominal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 48 hour timepoint | -0.07 log10 CFU/cm^2 | Standard Deviation 1.34 |
| Experimental Prep - Abdominal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 96 hour timepoint | -0.24 log10 CFU/cm^2 | Standard Deviation 1.35 |
| Experimental Prep - Abdominal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 72 hour timepoint | -0.57 log10 CFU/cm^2 | Standard Deviation 1.16 |
| Active Comparator Prep - Abdominal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 48 hour timepoint | -0.26 log10 CFU/cm^2 | Standard Deviation 1.37 |
| Active Comparator Prep - Abdominal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 96 hour timepoint | -0.25 log10 CFU/cm^2 | Standard Deviation 1.55 |
| Active Comparator Prep - Abdominal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 72 hour timepoint | -0.49 log10 CFU/cm^2 | Standard Deviation 1.35 |
| Experimental Prep - Inguinal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 72 hour timepoint | 0.21 log10 CFU/cm^2 | Standard Deviation 1.63 |
| Experimental Prep - Inguinal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 48 hour timepoint | 0.24 log10 CFU/cm^2 | Standard Deviation 1.42 |
| Experimental Prep - Inguinal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 96 hour timepoint | 0.66 log10 CFU/cm^2 | Standard Deviation 2.04 |
| Active Comparator Prep - Inguinal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 48 hour timepoint | 0.44 log10 CFU/cm^2 | Standard Deviation 1.56 |
| Active Comparator Prep - Inguinal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 96 hour timepoint | 1.08 log10 CFU/cm^2 | Standard Deviation 1.81 |
| Active Comparator Prep - Inguinal Site | Change in Skin Flora Relative to 10 Minutes Post-prep Application | 72 hour timepoint | 0.75 log10 CFU/cm^2 | Standard Deviation 1.78 |
Comparison: 48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment.p-value: 0.3895% CI: [-0.63, 0.24]Paired t-test
Comparison: 72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment.p-value: 0.6895% CI: [-0.3, 0.45]Paired t-test
Comparison: 96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment.p-value: 0.9795% CI: [-0.47, 0.45]Paired t-test
Comparison: 48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment.p-value: 0.495% CI: [-0.27, 0.65]Paired t-test
Comparison: 72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment.p-value: 0.0395% CI: [0.05, 1.03]Paired t-test
Comparison: 96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment.p-value: 0.0795% CI: [-0.03, 0.87]Paired t-test
Other Pre-specified
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderate, 3=severe.
Time frame: Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment
Population: Subjects meeting required baseline counts: greater or equal to 3.00 log10 CFU/cm\^2 on the abdominal region and greater than or or equal to 5.00 log10 CFU/cm\^2 on the inguinal region.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:Baseline pre-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:10 min post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:72 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:48 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:Baseline pre-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:72 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:10-minute post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:72 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:Baseline pre-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:10 min post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:48 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:48 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:48 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:72 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:10 min post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:10 min post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:96 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:10 min post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:48 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:10 min post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:48 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:96 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:72 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:72 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:72 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:48 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:72 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:48 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:96 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:10-minute post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Abdominal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:48 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:Baseline pre-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:10-minute post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:48 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:72 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:Baseline pre-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:10 min post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:48 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:72 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:Baseline pre-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:10 min post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:72 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:10 min post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:48 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:72 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:96 hours post-treatment rating=0 | 62 sites |
| Experimental Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:96 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:72 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:48 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:10-minute post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:10 min post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:10 min post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Edema:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:48 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:96 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:72 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:96 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:48 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Rash:72 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:72 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:10 min post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:Baseline pre-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Dryness:48 hours post-treatment rating=0 | 62 sites |
| Active Comparator Prep - Inguinal Site | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | Erythema:96 hours post-treatment rating=0 | 62 sites |