Phase 2
N=30
Evaluation 2% Chlorhexidine Gluconate
Skin Coverage
Bottom Line
View on ClinicalTrials.gov: NCT03326726 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Medline 2% CHG Cloth Dosage of Coverage Area — 0.0081 g/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 2% CHG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Medline Industries
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medline 2% CHG Cloth Dosage of Coverage Area |
0.0081 | — |
| SECONDARY Post-application Drying Time |
70 | — |
Summary
Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin was allowed to air dry.
Eligibility Criteria
Inclusion Criteria
Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.
Data sourced from ClinicalTrials.gov (NCT03326726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.