Trial Outcomes & Findings for Cumulative Irritation Potential of 828 Ointment (NCT NCT00767455)
NCT ID: NCT00767455
Last Updated: 2014-03-14
Results Overview
Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale \[0 (no visible reaction) to 4 (severe erythema)\] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).
COMPLETED
PHASE1
59 participants
22 days
2014-03-14
Participant Flow
Healthy volunteers \>= 18 years of age
Participant milestones
| Measure |
HP828-101 vs. Negative Control vs. Positive Control
Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
HP828-101 vs. Negative Control vs. Positive Control
Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)
|
|---|---|
|
Overall Study
Investigator error
|
19
|
Baseline Characteristics
Cumulative Irritation Potential of 828 Ointment
Baseline characteristics by cohort
| Measure |
HP828-101 vs. Negative Control vs. Positive Control
n=59 Participants
each subject was their own control and received patches of all (test article, negative control, and positive control)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 22 daysPopulation: Per protocol
Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale \[0 (no visible reaction) to 4 (severe erythema)\] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).
Outcome measures
| Measure |
HP828-101
n=40 Participants
Intervention test article
|
Negative Control
n=40 Participants
Johnson's Baby Oil
|
Positive Control
n=40 Participants
Sodium Lauryl Sulfate
|
|---|---|---|---|
|
Presence of Cumulative Irritation
|
163.0 units on a scale
|
109.0 units on a scale
|
2073.0 units on a scale
|
Adverse Events
HP828-101 vs. Negative Control vs. Positive Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HP828-101 vs. Negative Control vs. Positive Control
n=59 participants at risk
each subject was their own control and received patches of all (test article, negative control, and positive control)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Tape Reaction
|
6.8%
4/59 • Number of events 4 • 22 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60