Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Phase 3

Completed

• Conditions: Surgery
• Interventions: Drug: 2% CHG Cloth solution; Device: Vehicle Cloth; Drug: Active Comparator; Other: Saline; Other: SLS

• Registration Number: NCT02224625
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-25
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-02-05
• Status Verified: 2016-03
• Results First Submitted QC: 2016-04-22
• Results First Posted: 2016-05-30
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Grading Scale for Visual Evaluation of Skin Condition	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

Trial Locations

Locations (1)

BioScience Laboratories; 🇺🇸 Butte, Montana, United States