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Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% CHG Cloth | Experimental | Chlorhexidine Gluconate 2% |
|
| Vehicle Cloth | Placebo Comparator | Excipients on cloth |
|
| DynaHex (2% CHG) | Active Comparator | Chlorhexidine Gluconate 2% solution |
|
| Saline | Sham Comparator | 0.9% sodium chloride |
|
| Sodium Lauryl Sulfate (SLS) | Active Comparator | Sodium lauryl sulfate to produce mild irritation as a positive control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% CHG Cloth solution | Drug | Investigational CHG |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Grading Scale for Visual Evaluation of Skin Condition | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Pullman, MD | BioScience Laboratories | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience Laboratories | Butte | Montana | 59701 | United States |
Data to be shared with FDA
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Participants received up to 5 products simultaneously on their skin. SLS was only used in the Irritation study (39 subjects) as a positive control.
39 of the 249 participants participated in both the Irritation and Sensitization Studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% CHG Cloth, Vehicle, DynaHex, Saline, SLS | Chlorhexidine Gluconate 2% cloth solution Vehicle solution of 2% CHG cloth DynaHex (2% CHG) 0.9% Saline Sodium Lauryl Sulfate |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Irritation |
|
| ||||||||||||||||||
| Sensitization |
|
Participants in the Sensitization study received the following 4 products ( 2% CHG cloth, Vehicle cloth, DynaHex and Saline). Participants in the Irritation study received the same 4 products in addition to SLS.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% CHG, Vehicle, DynaHex, Saline | Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Grading Scale for Visual Evaluation of Skin Condition | 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 | Participants received more than one product at a time. | Posted | Mean | Full Range | Scores Ranging (0-7) | 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249) |
|
Adverse events reported over a 21 (irritation) and 35 (sensitization) day period.
Participants received up to 5 different products simultaneously during the study. Adverse skin reactions with known relationships to the products applied were reported individually. Non-skin related adverse events were also captured during the study but could not be associated directly with a particular treatment and are not included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2% CHG Cloth | Chlorhexidine Gluconate 2% 2% CHG Cloth: CHG solution on cloth |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| C Beausoleil | Bioscience Labs | 406-587-5735 | cbeausoleil@bioscience.com |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D012965 | Sodium Chloride |
| D012967 | Sodium Dodecyl Sulfate |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Vehicle Cloth | Device | Excipients from CHG cloth only |
|
|
| Active Comparator | Drug | Active comparator |
|
|
| Saline | Other | Negative control |
|
| SLS | Other | Provides a slight irritation for a positive control |
|
|
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Vehicle Cloth | Excipients on cloth Vehicle Cloth: Excipients from CHG cloth only |
| OG002 | DynaHex (2% CHG) | Chlorhexidine Gluconate 2% solution Active Comparator: 2% CHG solution |
| OG003 | Saline | 0.9% sodium chloride Saline: Negative control |
| OG004 | Sodium Lauryl Sulfate (SLS) | Sodium lauryl sulfate to produce mild irritation as a positive control SLS: Provides a slight irritation for a positive control |
|
|
| 0 |
| 249 |
| 5 |
| 249 |
| EG001 | Vehicle Cloth | Excipients on cloth Vehicle Cloth: Excipients from CHG cloth only | 0 | 249 | 0 | 249 |
| EG002 | DynaHex (2% CHG) | Chlorhexidine Gluconate 2% solution Active Comparator: 2% CHG solution | 0 | 249 | 15 | 249 |
| EG003 | Saline | 0.9% sodium chloride Saline: Negative control | 0 | 249 | 0 | 249 |
| EG004 | Sodium Lauryl Sulfate (SLS) | Sodium lauryl sulfate to produce mild irritation as a positive control SLS: Provides a slight irritation for a positive control | 0 | 39 | 1 | 39 |
| Irritation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Confidential information based on contract
| D017670 |
| Sodium Compounds |
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |