Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

January 27, 2017 updated by: Medline Industries

Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product

Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day.

The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Butte, Montana, United States, 59701
        • BioScience Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Free of skin disorders
  • Signed consent

Exclusion Criteria:

  • Allergies to latex
  • Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
  • severe illness
  • Pregnant (females)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2% CHG Cloth
Chlorhexidine Gluconate 2%
Drug: 2% CHG Cloth solution
Investigational CHG
Other Names:
  • Chlorhexidine Gluconate
Placebo Comparator: Vehicle Cloth
Excipients on cloth
Device: Vehicle Cloth
Excipients from CHG cloth only
Other Names:
  • Control
Active Comparator: DynaHex (2% CHG)
Chlorhexidine Gluconate 2% solution
Drug: Active Comparator
Active comparator
Other Names:
  • DynaHex-2
Sham Comparator: Saline
0.9% sodium chloride
Other: Saline
Negative control
Active Comparator: Sodium Lauryl Sulfate (SLS)
Sodium lauryl sulfate to produce mild irritation as a positive control
Other: SLS
Provides a slight irritation for a positive control
Other Names:
  • Sodium Lauryl Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grading Scale for Visual Evaluation of Skin Condition
Time Frame: 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)

Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.

Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.

Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading
21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medline Industries

Investigators

  • Principal Investigator: J Pullman, MD, BioScience Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R13-051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data to be shared with FDA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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