Trial Outcomes & Findings for Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel (NCT NCT02576847)
NCT ID: NCT02576847
Last Updated: 2022-07-19
Results Overview
Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
307 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2022-07-19
Participant Flow
The study was conducted at 28 sites in the USA, Canada, Australia/New Zealand, and Europe from October 2015 to July 2017.
Participant milestones
| Measure |
Treatment
Omiganan gel applied once daily
Omiganan: Topical gel
|
|---|---|
|
Overall Study
STARTED
|
307
|
|
Overall Study
COMPLETED
|
170
|
|
Overall Study
NOT COMPLETED
|
137
|
Reasons for withdrawal
| Measure |
Treatment
Omiganan gel applied once daily
Omiganan: Topical gel
|
|---|---|
|
Overall Study
Adverse Event
|
27
|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
78
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
Baseline characteristics by cohort
| Measure |
Treatment
n=307 Participants
Omiganan gel applied once daily
Omiganan: Topical gel
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
243 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
64 Participants
n=99 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 13.57 • n=99 Participants
|
|
Sex: Female, Male
Female
|
205 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
80 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
227 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
286 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
New Zealand
|
34 participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
24 participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
187 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=99 Participants
|
|
Region of Enrollment
Australia
|
37 participants
n=99 Participants
|
|
Region of Enrollment
France
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsNumber of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Outcome measures
| Measure |
Treatment
n=307 Participants
Omiganan gel applied once daily
Omiganan: Topical gel
|
|---|---|
|
Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
|
48 participants
|
Adverse Events
Treatment
Serious events: 7 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=307 participants at risk
Omiganan gel applied once daily
Omiganan: Topical gel
|
|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.33%
1/307 • Number of events 1 • 378 Days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
1/307 • Number of events 1 • 378 Days
|
|
Nervous system disorders
Dizziness
|
0.33%
1/307 • Number of events 1 • 378 Days
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
0.33%
1/307 • Number of events 1 • 378 Days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
1/307 • Number of events 1 • 378 Days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.33%
1/307 • Number of events 1 • 378 Days
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.33%
1/307 • Number of events 1 • 378 Days
|
Other adverse events
| Measure |
Treatment
n=307 participants at risk
Omiganan gel applied once daily
Omiganan: Topical gel
|
|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.9%
12/307 • Number of events 13 • 378 Days
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
9/307 • Number of events 14 • 378 Days
|
|
General disorders
Application site pain
|
3.3%
10/307 • Number of events 12 • 378 Days
|
|
General disorders
Application site erythema
|
2.6%
8/307 • Number of events 8 • 378 Days
|
|
General disorders
Application site dryness
|
2.3%
7/307 • Number of events 7 • 378 Days
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
6.8%
21/307 • Number of events 28 • 378 Days
|
|
Nervous system disorders
Headache
|
5.2%
16/307 • Number of events 34 • 378 Days
|
Additional Information
Maruho Co.,Ltd. Kyoto R&D Center
Clinical Development Dept.
Phone: +81-75-325-3255
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place