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Completed

NCT Number: NCT02224625

Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

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

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Key information

Conditions

Surgery

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BioScience Laboratories

Butte, Montana, 59701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

2% CHG Cloth solution

Drug

Investigational CHG

Other names: Chlorhexidine Gluconate

Vehicle Cloth

Device

Excipients from CHG cloth only

Other names: Control

Active Comparator

Drug

Active comparator

Other names: DynaHex-2

Saline

Other

Negative control

SLS

Other

Provides a slight irritation for a positive control

Other names: Sodium Lauryl Sulfate

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2014
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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