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Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle

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ClinicalTrials.gov Identifier: NCT02578771
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Zurex Pharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: ZuraPrep with 70% IPA Drug: ZuraPrep without 70% IPA Drug: ChloraPrep CHG/IPA Teal Tint Other: Normal Saline Phase 3

Detailed Description:

The single investigational test article, ZuraPrep solution 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.

The primary objective of this study is to characterize the in vivo effects of the ZuraPrep test article compared to the positive reference control ChloraPrep, as well as to evaluate the ZuraPrep test vehicle to the negative control, Saline, using the newly proposed sampling intervals.

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. Treatments will be evaluated at 30 seconds, 10 minutes and 6 hour sampling intervals compared to baseline. Status will be calculated separately for the abdomen and groin for each side of the body.

Study duration for subjects - 3 to 4 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Pilot Clinical Evaluation to Characterize the in Vivo Effects of Topically Applied ZuraPrep and ZuraPrep Vehicle
Study Start Date : October 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: ZuraPrep with 70% Isopropyl alcohol
Test Article ZuraPrep with 70% isopropyl alcohol (IPA) will be compared with reference positive control Chloraprep
Drug: ZuraPrep with 70% IPA
Apply topically
Other Name: 70% IPA

Drug: ChloraPrep CHG/IPA Teal Tint
Apply topically
Other Name: CHG 2% / IPA 70%

Experimental: ZuraPrep without 70% IPA
Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline
Drug: ZuraPrep without 70% IPA
Apply topically. 0% IPA
Other Name: ZuraPrep Vehicle

Other: Normal Saline
Apply topically
Other Name: 0.85% Sodium Chloride (NaCl)

Active Comparator: ChloraPrep Teal Tint
Test Article ZuraPrep with 70% isopropyl alcohol will be compared with reference positive control ChloraPrep [Chlorhexidine gluconate(CHG)/IPA] Teal Tint
Drug: ZuraPrep with 70% IPA
Apply topically
Other Name: 70% IPA

Drug: ChloraPrep CHG/IPA Teal Tint
Apply topically
Other Name: CHG 2% / IPA 70%

Placebo Comparator: Normal Saline 0.85%
Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline 0.85%
Drug: ZuraPrep without 70% IPA
Apply topically. 0% IPA
Other Name: ZuraPrep Vehicle

Other: Normal Saline
Apply topically
Other Name: 0.85% Sodium Chloride (NaCl)




Primary Outcome Measures :
  1. Reduction of skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment [ Time Frame: 30 seconds ]
    calculated as log-10 CFU responder rates from baseline

  2. Reduction of skin flora measured by 1994 TFM [ Time Frame: 10 minutes ]
    calculated as log-10 CFU reductions from baseline


Secondary Outcome Measures :
  1. Skin flora measurement [ Time Frame: 6 hours ]
    The bacterial counts should not exceed baseline at the 6 hour sampling time



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578771


Locations
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United States, Virginia
MicroBioTest
Sterling, Virginia, United States, 20164
Sponsors and Collaborators
Zurex Pharma, Inc.
Investigators
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Principal Investigator: M. Hamid Barshir, MD MicroBioTest

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Responsible Party: Zurex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02578771     History of Changes
Other Study ID Numbers: ZX-ZP-0068 (MBT#865-104)
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents