An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes

• Status: Completed
• Trial end date: 2019-09-18
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gama Healthcare Ltd.
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

• Male and female participants 18 - 70 years, who have provided written informed consent to participate in the study

• Test sites with a bacterial baseline count of ≥ 5.0 log10/cm2 at the inguinal (groin) test administration sites. ≥4.0 log10/cm2 at the abdominal test site and >3.0 log10/cm2 at the clavicular and/or median cubital regions at Day - 5 of screening

• Participants, who in the opinion of the Investigator, are in suitable health for inclusion in the study.

Exclusion Criteria:

• Exposure of the test sites to strong detergents, solvents or other irritants during the 14- day pre-test conditioning period or during the test period.

• Use of systemic or topical antibiotic medications, steroid medications or any other product known to affect the normal microbial flora of the skin, up to 1 month prior to the screening period, during the 14-day pre-test conditioning period or during the test period.

• Any known allergies to latex (rubber), alcohols, tape adhesives or to common antibacterial agents found in soaps, lotions or ointments, particularly chlorhexidine gluconate or chlorine.

• Active skin rashes or breaks in the skin at the test site.

• Active skin diseases or inflammatory skin conditions including contact dermatitis within 10cm of the test site.

• Showering or bathing after the Day -5 baseline sampling and unwilling to refrain from showering or bathing whilst at Surrey CRC (Day 0 to Day 1).

• Participation in another clinical trial within 90 days preceding randomisation.

• Pregnant or breastfeeding women.

• Any other medical condition, which in the opinion of the Investigator, should preclude participation.

• Unwillingness to fulfil the performance requirements of the study.