Phase 1
N=12
Single Dose CHG Pharmacokinetic Study
Surgical Skin Preparation
Bottom Line
View on ClinicalTrials.gov: NCT03331263 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Chlorhexidine Gluconate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medline Industries
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. |
0; 0; 0 | — |
| SECONDARY Number of Subjects With of Treatment Emergent Adverse Events. |
1; 1; 1 | — |
Summary
A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.
Eligibility Criteria
Inclusion Criteria
- Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:
- non- or ex-smokers
- body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg
- negative pregnancy test for female subjects
- healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)
Data sourced from ClinicalTrials.gov (NCT03331263). 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.