Trial Outcomes & Findings for Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis (NCT NCT00843466)
NCT ID: NCT00843466
Last Updated: 2018-09-10
Results Overview
Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Wk 4
Results posted on
2018-09-10
Participant Flow
Recruitment was from May 22,2007 to May 12, 2008 at Wake Forest University in Winston Salem.
Participant milestones
| Measure |
Test Product
The test group was provided with a test product for all hand cleansing needs during the duration of the study.
|
Control Group (Current Product)
The control group continued to use their current cleanser for hand washing.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
18
|
|
Overall Study
COMPLETED
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
Baseline characteristics by cohort
| Measure |
Test Product
n=24 Participants
The test group was provided with a test product for all hand cleansing needs during the duration of the study.
|
Control Group (Current Product)
n=18 Participants
The control group continued to use their current cleanser for hand washing.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
n=5 Participants
|
40 years
n=7 Participants
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
18 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Wk 4Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe
Outcome measures
| Measure |
Mild Moisturizing Hand Cleanser Test Product
n=24 Participants
The test group was provided with a test product for all hand cleansing needs during the duration of the study.
|
No Treatment
n=18 Participants
The control group continued to use their current cleanser for hand washing.
|
|---|---|---|
|
Investigator Global Assessment
|
1.0 units on a scale
Interval 0.8 to 1.2
|
1.1 units on a scale
Interval 0.7 to 1.4
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (Current Product)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place