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Trial record 3 of 565 for:    applied AND irritation

Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA

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ClinicalTrials.gov Identifier: NCT02160587
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Zurex Pharma, Inc.

Brief Summary:
This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Chloraprep Drug: 0.9% Physiological Saline Other: ZuraPrep without IPA Phase 1

Detailed Description:
This study is designed to determine if the test product, ZuraPrep™ is a skin sensitizing agent when applied to human skin. The study, a modified Draize skin sensitization evaluation, will be conducted in three discrete phases: 1) induction, 2) rest, and 3) challenge. During the Induction Phase, skin sites are exposed to the test product repeatedly for 21 consecutive days. The Rest Phase, a 14-day period when no treatment is performed, serves to provide adequate time for the immune system to react to ZuraPrep™, given any of its components serve as antigens. During the Challenge Phase, the subjects' skin is re-exposed to the test product (ZuraPrep™) to determine if it is likely to be immunosensitizing.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Active Comparator: ZuraPrep
Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.
Drug: Chloraprep
ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.
Other Names:
  • Reference Product
  • 2% Chlorhexidine Gluconate and 70% IPA

Drug: 0.9% Physiological Saline
0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.
Other Name: Negative Control

Other: ZuraPrep without IPA
ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation
Other Name: ZuraPrep without Isopropyl Alcohol (IPA)




Primary Outcome Measures :
  1. Skin sites evaluated and graded for irritancy or sensitization [ Time Frame: 0-40 days post dose ]
    Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization. Reactions observed will be assessed as to whether indicative of sensitization or of irritation.


Secondary Outcome Measures :
  1. Statistics of irritation scores [ Time Frame: 0-40 days post dose ]
    Irritation scores, relative to the Test Products, Reference Product, and the Negative Control applied to skin on each test day will be compared as well as the total cumulative irritation scores across all test days.



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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:

  • Subjects may be of either sex, at least 18 years of age and of any race
  • Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back.
  • Subjects must be in good general health

Exclusion Criteria:

  • Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate.
  • Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period.
  • Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period.
  • Current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as AIDS or HIV positive.
  • Pregnancy, plans to become pregnant, breast-feeding
  • Any active skin rash or breaks in the skin of the back
  • Any sunburn or tattoos on the skin of the back
  • Current active skin disease or inflammatory skin condition including contact dermatitis
  • Participation in a clinical study in the past 7 days or current participation in another clinical study
  • Any medical condition or use of any medications that, in the opinion of the Principal Investigator, would preclude participation
  • Unwillingness to fulfill the performance requirements of the 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): NCT02160587


Locations
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United States, Montana
BioScience Laboratories, Inc.
Bozeman, Montana, United States, 59718
Sponsors and Collaborators
Zurex Pharma, Inc.
Investigators
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Principal Investigator: Maggie Butler, PhD BioScience Laboratories, Inc.

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Responsible Party: Zurex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02160587     History of Changes
Other Study ID Numbers: 130821-303 (ZX-ZP-0018)
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

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