Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Overview

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

Full Title of Study: “Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2015

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.

Interventions

  • Drug: 2% CHG Cloth solution
    • Investigational CHG
  • Device: Vehicle Cloth
    • Excipients from CHG cloth only
  • Drug: Active Comparator
    • Active comparator
  • Other: Saline
    • Negative control
  • Other: SLS
    • Provides a slight irritation for a positive control

Arms, Groups and Cohorts

  • Experimental: 2% CHG Cloth
    • Chlorhexidine Gluconate 2%
  • Placebo Comparator: Vehicle Cloth
    • Excipients on cloth
  • Active Comparator: DynaHex (2% CHG)
    • Chlorhexidine Gluconate 2% solution
  • Sham Comparator: Saline
    • 0.9% sodium chloride
  • Active Comparator: Sodium Lauryl Sulfate (SLS)
    • Sodium lauryl sulfate to produce mild irritation as a positive control

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medline Industries
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • J Pullman, MD, Principal Investigator, BioScience Laboratories

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