Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle
1 other identifier
interventional
123
1 country
1
Brief Summary
ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product and reference positive control will be compared; ZuraPrep non-active and negative control will be compared. Each subject will receive two of the planned treatments, one on the left side of body and one of the right. Study duration for subjects - 3 to 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJuly 17, 2017
July 1, 2017
3 months
October 8, 2015
July 13, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Reduction of skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment
calculated as log-10 CFU responder rates from baseline
30 seconds
Reduction of skin flora measured by 1994 TFM
calculated as log-10 CFU reductions from baseline
10 minutes
Secondary Outcomes (1)
Skin flora measurement
6 hours
Study Arms (4)
ZuraPrep with 70% Isopropyl alcohol
EXPERIMENTALTest Article ZuraPrep with 70% isopropyl alcohol (IPA) will be compared with reference positive control Chloraprep
ZuraPrep without 70% IPA
EXPERIMENTALVehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline
ChloraPrep Teal Tint
ACTIVE COMPARATORTest Article ZuraPrep with 70% isopropyl alcohol will be compared with reference positive control ChloraPrep \[Chlorhexidine gluconate(CHG)/IPA\] Teal Tint
Normal Saline 0.85%
PLACEBO COMPARATORVehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline 0.85%
Interventions
Apply topically
Apply topically. 0% IPA
Apply topically
Apply topically
Eligibility Criteria
You may qualify if:
- Healthy male and female volunteers, 18 years of age or older.
- Are in good general health.
- Have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.
- Cooperative and willing to follow Subject Instructions.
- Cooperative and willing to sign Consent Form and HIPAA Authorization Form.
- Have acceptable Screening Day baseline counts (CFU/cm2).
You may not qualify if:
- Topical or systemic antimicrobial exposure within 14 days prior to Screening Day. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, colognes, and topical or systemic antibiotics.
- Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within 14 days prior to Screening Day.
- Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable test areas) within 14 days prior to Screening Day.
- Contact with solvents, acids, bases, fabric softener-treated clothing or other household chemicals in the applicable test areas within 14 days prior to Screening Day.
- Subjects who have a history of sensitivity to natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), isopropyl alcohol, citric acid, methylene blue, methylparaben, propylparaben, or chlorhexidine gluconate products.
- Subjects who have a history of skin allergies.
- Subjects who have a history of skin cancer within 6 inches of the applicable test areas.
- Subjects who are pregnant, attempting pregnancy or nursing. For all females of child-bearing potential (\<60 years of age), a urine pregnancy test will be performed prior to treatment on Treatment Day.
- Subjects who have showered or bathed within 72 hours of the Screening Day or Treatment Day (sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided).
- Subjects who receive an irritation score of 1 for any individual skin condition prior to Screening Day baseline or Treatment Day baseline sample collection.
- Participation in another clinical trial in the 30 days prior to Test Day of this study (treatment with test materials in this study), or be currently enrolled in another clinical trial, or has previously participated in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MicroBioTest
Sterling, Virginia, 20164, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M. Hamid Barshir, MD
MicroBioTest
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2015
First Posted
October 19, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
July 17, 2017
Record last verified: 2017-07