Trial Outcomes & Findings for A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis (NCT NCT02336503)
NCT ID: NCT02336503
Last Updated: 2023-03-15
Results Overview
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
Baseline through Week 4 (Day 29)
Results posted on
2023-03-15
Participant Flow
Participant milestones
| Measure |
BBI-4000 Gel, 5%
BBI-4000 Gel, 5% Applied to both axillae once nightly
|
BBI-4000 Gel, 10%
BBI-4000 Gel, 10% Applied to both axillae once nightly
|
BBI-4000 Gel, 15%
BBI-4000 Gel, 15% Applied to both axillae once nightly
|
Vehicle
Vehicle (placebo) applied to both axillae nightly
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
48
|
46
|
|
Overall Study
COMPLETED
|
45
|
45
|
47
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
6
|
Reasons for withdrawal
| Measure |
BBI-4000 Gel, 5%
BBI-4000 Gel, 5% Applied to both axillae once nightly
|
BBI-4000 Gel, 10%
BBI-4000 Gel, 10% Applied to both axillae once nightly
|
BBI-4000 Gel, 15%
BBI-4000 Gel, 15% Applied to both axillae once nightly
|
Vehicle
Vehicle (placebo) applied to both axillae nightly
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
4
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Baseline characteristics by cohort
| Measure |
BBI-4000 Dose 1
n=47 Participants
Low concentration of BBI-4000
BBI-4000 Low Concentration: BBI-4000 Low Dose
|
BBI-4000 Dose 2
n=48 Participants
Middle concentration of BBI-4000
BBI-4000 Middle Concentration: BBI-4000 Middle Dose
|
BBI-4000 Dose 3
n=48 Participants
High concentration of BBI-4000
BBI-4000 High Concentration: BBI-4000 High Dose
|
Vehicle
n=46 Participants
Vehicle (placebo)
Placebo: Vehicle
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 10.61 • n=7 Participants
|
35.5 years
STANDARD_DEVIATION 11.64 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 8.23 • n=4 Participants
|
33.5 years
STANDARD_DEVIATION 10.30 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 4 (Day 29)Population: Randomized subjects with reported scores on Baseline and Day 29 (week 4), Count of participants includes number of participants who did not report at-least a 2-point decrease in score (NO) and number of participants who did report at-least a 2-point decrease in score (YES); proportions were calculated as percentages = (# of participants/total # of participants that provided baseline and day 29 HDSS scores) x 100%
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Outcome measures
| Measure |
BBI-4000 Gel, 5%
n=47 Participants
Low concentration of BBI-4000
BBI-4000 Gel, 5% Applied to both axillae once nightly
|
BBI-4000 Gel, 10%
n=47 Participants
Middle concentration of BBI-4000
BBI-4000 Gel, 10% Applied to both axillae once nightly
|
BBI-4000 Gel, 15%
n=47 Participants
High concentration of BBI-4000
BBI-4000 Gel, 15% Applied to both axillae once nightly
|
Vehicle
n=41 Participants
Vehicle (placebo)
Placebo: Vehicle
|
|---|---|---|---|---|
|
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
No
|
35 Participants
|
37 Participants
|
29 Participants
|
36 Participants
|
|
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Yes
|
12 Participants
|
10 Participants
|
18 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 4 (Day 29)Population: Randomized subjects with reported scores on Baseline and Day 29 (week 4), Count of participants includes number of participants who did not report at-least a 1-point decrease in score (NO) and number of participants who did report at-least a 1-point decrease in score (YES); proportions were calculated as percentages = (# of participants YES or NO/total # of participants that provided baseline and day 29 HDSS scores) x 100%
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Outcome measures
| Measure |
BBI-4000 Gel, 5%
n=47 Participants
Low concentration of BBI-4000
BBI-4000 Gel, 5% Applied to both axillae once nightly
|
BBI-4000 Gel, 10%
n=47 Participants
Middle concentration of BBI-4000
BBI-4000 Gel, 10% Applied to both axillae once nightly
|
BBI-4000 Gel, 15%
n=47 Participants
High concentration of BBI-4000
BBI-4000 Gel, 15% Applied to both axillae once nightly
|
Vehicle
n=41 Participants
Vehicle (placebo)
Placebo: Vehicle
|
|---|---|---|---|---|
|
Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
No
|
25 Participants
|
26 Participants
|
13 Participants
|
23 Participants
|
|
Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Yes
|
22 Participants
|
21 Participants
|
34 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 4 (Day 29)Population: Randomized participants that provided samples for gravimetric measured sweat production: baseline and day 29
Sweat production unit of measure was weight-based (mg); absolute change was calculated by adding the left and right axillae sweat weights and calculating absolute change by subtracting day 29 from baseline sweat weights
Outcome measures
| Measure |
BBI-4000 Gel, 5%
n=47 Participants
Low concentration of BBI-4000
BBI-4000 Gel, 5% Applied to both axillae once nightly
|
BBI-4000 Gel, 10%
n=47 Participants
Middle concentration of BBI-4000
BBI-4000 Gel, 10% Applied to both axillae once nightly
|
BBI-4000 Gel, 15%
n=47 Participants
High concentration of BBI-4000
BBI-4000 Gel, 15% Applied to both axillae once nightly
|
Vehicle
n=41 Participants
Vehicle (placebo)
Placebo: Vehicle
|
|---|---|---|---|---|
|
Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)
|
-183.1 mg
Standard Deviation 370.85
|
-56.4 mg
Standard Deviation 277.81
|
-171.9 mg
Standard Deviation 344.54
|
-172.9 mg
Standard Deviation 315.89
|
SECONDARY outcome
Timeframe: Baseline through Week 4 (Day 29)Population: Randomized participants that provided samples for gravimetric sweat measures, baseline and day 29;
Randomized participants that provided samples for gravimetric sweat measures, baseline and day 29; Percent Change was calculated by dividing absolute change by baseline gravimetric measurement x 100%
Outcome measures
| Measure |
BBI-4000 Gel, 5%
n=47 Participants
Low concentration of BBI-4000
BBI-4000 Gel, 5% Applied to both axillae once nightly
|
BBI-4000 Gel, 10%
n=47 Participants
Middle concentration of BBI-4000
BBI-4000 Gel, 10% Applied to both axillae once nightly
|
BBI-4000 Gel, 15%
n=47 Participants
High concentration of BBI-4000
BBI-4000 Gel, 15% Applied to both axillae once nightly
|
Vehicle
n=41 Participants
Vehicle (placebo)
Placebo: Vehicle
|
|---|---|---|---|---|
|
Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4
|
-31.9 percentage of change
Standard Deviation 84.95
|
-15.7 percentage of change
Standard Deviation 115.03
|
-35.7 percentage of change
Standard Deviation 65.48
|
-41.7 percentage of change
Standard Deviation 40.73
|
Adverse Events
BBI-4000 Gel, 5%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BBI-4000 Gel, 10%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
BBI-4000 Gel, 15%
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BBI-4000 Gel, 5%
n=47 participants at risk
BBI-4000 Gel, 5%, administered to each axillae nightly
|
BBI-4000 Gel, 10%
n=48 participants at risk
BBI-4000 Gel, 10%, administered to each axillae nightly
|
BBI-4000 Gel, 15%
n=48 participants at risk
BBI-4000 Gel, 15%, administered to each axillae nightly
|
Vehicle
n=46 participants at risk
BBI-4000 Gel, 0% (Placebo)
|
|---|---|---|---|---|
|
Eye disorders
Dry Eye
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Eye disorders
Vision Blurred
|
4.3%
2/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
4.2%
2/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
6.2%
3/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Gastrointestinal disorders
Dry Mouth
|
4.3%
2/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
4.2%
2/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
8.3%
4/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Gastrointestinal disorders
Lip Dry
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Gastrointestinal disorders
Tooth Ache
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.2%
1/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
General disorders
Application Site Dermatitis
|
4.3%
2/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
General disorders
Application Site Dryness
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
General disorders
Application Site Erythema
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
General disorders
Application Site Pain
|
4.3%
2/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
4.2%
2/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
General disorders
Application Site Pruritus
|
4.3%
2/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
General disorders
Application Site Rash
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
4.2%
2/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
General disorders
Application Site Swelling
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Application Site Folliculitis
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Bacterial Vaginosis
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.2%
1/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Dermatitis Infected
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Gastroenteritis
|
2.1%
1/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
4.3%
2/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Sinusitis
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
4.3%
2/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
2.1%
1/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.2%
1/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Investigations
Crystal Urine Present
|
2.1%
1/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Nervous system disorders
Headache
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Renal and urinary disorders
Haematuria
|
2.1%
1/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Renal and urinary disorders
Urinary Hesitation
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/47 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
2.1%
1/48 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
0.00%
0/46 • Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Adverse event definitions followed clinicaltrials.gov guidance
|
Additional Information
Vice President, Head of Development
Botanix Pharmaceuticals
Phone: +1 (445) 300-3403
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement terms prioritized a multi-center publication at the study end. Should such a publication not be completed, an investigator right to individually publish results of his/her study (limited to his/her site data) was included, if for purely scientific or educational purposes; not for any commercial purposes. PI(s) were to submit draft materials to the Sponsor 60 days prior to Investigator release of individual abstract or manuscript. Additional disclosure restrictions and terms applied .
- Publication restrictions are in place
Restriction type: OTHER