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Trial record 20 of 49 for:    Sodium Lauryl Sulfate

Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

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ClinicalTrials.gov Identifier: NCT02224625
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : May 30, 2016
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Medline Industries

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

Condition or disease Intervention/treatment Phase
Surgery Drug: 2% CHG Cloth solution Device: Vehicle Cloth Drug: Active Comparator Other: Saline Other: SLS Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Experimental: 2% CHG Cloth
Chlorhexidine Gluconate 2%
Drug: 2% CHG Cloth solution
Investigational CHG
Other Name: Chlorhexidine Gluconate

Placebo Comparator: Vehicle Cloth
Excipients on cloth
Device: Vehicle Cloth
Excipients from CHG cloth only
Other Name: Control

Active Comparator: DynaHex (2% CHG)
Chlorhexidine Gluconate 2% solution
Drug: Active Comparator
Active comparator
Other Name: 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 Name: Sodium Lauryl Sulfate




Primary Outcome Measures :
  1. 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




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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT02224625


Locations
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United States, Montana
BioScience Laboratories
Butte, Montana, United States, 59701
Sponsors and Collaborators
Medline Industries
Investigators
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Principal Investigator: J Pullman, MD BioScience Laboratories

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Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT02224625     History of Changes
Other Study ID Numbers: R13-051
First Posted: August 25, 2014    Key Record Dates
Results First Posted: May 30, 2016
Last Update Posted: March 9, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data to be shared with FDA
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents