Trial Outcomes & Findings for Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth (NCT NCT02224625)
NCT ID: NCT02224625
Last Updated: 2017-03-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
249 participants
Primary outcome timeframe
21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)
Results posted on
2017-03-09
Participant Flow
39 of the 249 participants participated in both the Irritation and Sensitization Studies.
Participants received up to 5 products simultaneously on their skin. SLS was only used in the Irritation study (39 subjects) as a positive control.
Participant milestones
| Measure |
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
|
|---|---|
|
Irritation
STARTED
|
39
|
|
Irritation
COMPLETED
|
33
|
|
Irritation
NOT COMPLETED
|
6
|
|
Sensitization
STARTED
|
249
|
|
Sensitization
COMPLETED
|
194
|
|
Sensitization
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Irritation
Adverse Event
|
6
|
|
Sensitization
Adverse Event
|
55
|
Baseline Characteristics
Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth
Baseline characteristics by cohort
| Measure |
2% CHG, Vehicle, DynaHex, Saline
n=249 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
226 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
249 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)Population: Participants received more than one product at a time.
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
Outcome measures
| Measure |
2% CHG Cloth
n=249 Participants
Chlorhexidine Gluconate 2%
2% CHG Cloth: CHG solution on cloth
|
Vehicle Cloth
n=249 Participants
Excipients on cloth
Vehicle Cloth: Excipients from CHG cloth only
|
DynaHex (2% CHG)
n=249 Participants
Chlorhexidine Gluconate 2% solution
Active Comparator: 2% CHG solution
|
Saline
n=249 Participants
0.9% sodium chloride
Saline: Negative control
|
Sodium Lauryl Sulfate (SLS)
n=39 Participants
Sodium lauryl sulfate to produce mild irritation as a positive control
SLS: Provides a slight irritation for a positive control
|
|---|---|---|---|---|---|
|
Grading Scale for Visual Evaluation of Skin Condition
Irritation Mean Visualization Score Baseline
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
|
Grading Scale for Visual Evaluation of Skin Condition
Irritation Mean Visualization Score Day 21
|
2.9 Scores Ranging (0-7)
Interval 0.0 to 4.0
|
1.4 Scores Ranging (0-7)
Interval 0.0 to 4.0
|
3.3 Scores Ranging (0-7)
Interval 3.0 to 4.0
|
0.7 Scores Ranging (0-7)
Interval 0.0 to 3.0
|
3.0 Scores Ranging (0-7)
Interval 3.0 to 3.0
|
|
Grading Scale for Visual Evaluation of Skin Condition
Sensitization Mean Visualization Score Baseline
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
|
Grading Scale for Visual Evaluation of Skin Condition
Sensitization Mean Visualization Score Day 35
|
0.12 Scores Ranging (0-7)
Interval 0.0 to 2.0
|
0.03 Scores Ranging (0-7)
Interval 0.0 to 2.0
|
0.03 Scores Ranging (0-7)
Interval 0.0 to 2.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
0 Scores Ranging (0-7)
Interval 0.0 to 0.0
|
Adverse Events
2% CHG Cloth
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vehicle Cloth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DynaHex (2% CHG)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Lauryl Sulfate (SLS)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2% CHG Cloth
n=249 participants at risk
Chlorhexidine Gluconate 2%
2% CHG Cloth: CHG solution on cloth
|
Vehicle Cloth
n=249 participants at risk
Excipients on cloth
Vehicle Cloth: Excipients from CHG cloth only
|
DynaHex (2% CHG)
n=249 participants at risk
Chlorhexidine Gluconate 2% solution
Active Comparator: 2% CHG solution
|
Saline
n=249 participants at risk
0.9% sodium chloride
Saline: Negative control
|
Sodium Lauryl Sulfate (SLS)
n=39 participants at risk
Sodium lauryl sulfate to produce mild irritation as a positive control
SLS: Provides a slight irritation for a positive control
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
3/249 • Number of events 3 • 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.
|
0.00%
0/249 • 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.
|
4.8%
12/249 • Number of events 12 • 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.
|
0.00%
0/249 • 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.
|
0.00%
0/39 • 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.
|
|
Skin and subcutaneous tissue disorders
Irritation
|
0.80%
2/249 • Number of events 2 • 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.
|
0.00%
0/249 • 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.
|
1.2%
3/249 • Number of events 3 • 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.
|
0.00%
0/249 • 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.
|
2.6%
1/39 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidential information based on contract
- Publication restrictions are in place
Restriction type: OTHER