Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 49 for:    Sodium Lauryl Sulfate

Safety Study to Evaluate the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160574
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Zurex Pharma, Inc.

Brief Summary:
This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: ChloraPrep Drug: 0.1% Sodium Lauryl Sulfate Drug: 0.9% Physiological Saline Other: ZuraPrep without IPA Phase 1

Detailed Description:
This cumulative irritation evaluation is designed to determine the skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol (IPA) after repetitive patch application to skin of healthy human subjects.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: A 21-Day Evaluation of the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ZuraPrep
ZuraPrep will be compared statistically to ZuraPrep without IPA and both to the Positive Control (0.1% Sodium Lauryl Sulfate). The degree of skin irritation caused by the Reference Product (ChloraPrep) and the Negative Control (0.9% Physiological Saline) will be graded.
Drug: ChloraPrep
The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without IPA.
Other Names:
  • Reference Product
  • 2% Chlorhexidine Gluconate and 70% IPA

Drug: 0.1% Sodium Lauryl Sulfate
The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA.
Other Name: Positive Control

Drug: 0.9% Physiological Saline
The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA.
Other Name: Negative Control

Other: ZuraPrep without IPA
Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA
Other Name: ZuraPrep without Isopropol Alcohol (IPA)




Primary Outcome Measures :
  1. Scoring Scale (0-7) for Visual Evaluation of Skin Condition [ Time Frame: 0-21 days post dose ]
    Results from skin scores of ZuraPrep and ZuraPrep without IPA will be compared statistically, and both will be compared to the Positive Control (0.1% Sodium Lauryl Sulfate).


Secondary Outcome Measures :
  1. Scoring Scale (0-7) for Visual Evaluation of Skin Condition [ Time Frame: 0-21 days post dose ]
    The degree of skin irritation caused by the Reference Product (ChloraPrep) and the Negative Control (0.9% Physiological Saline) will be graded.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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): NCT02160574


Locations
Layout table for location information
United States, Montana
BioScience Laboratories
Bozeman, Montana, United States, 59718
Sponsors and Collaborators
Zurex Pharma, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Esther Campbell BioScience Laboratories, Inc.

Layout table for additonal information
Responsible Party: Zurex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02160574     History of Changes
Other Study ID Numbers: 130820-302 (ZX-ZP-0017)
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents