Trial Outcomes & Findings for Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea (NCT NCT03064438)
NCT ID: NCT03064438
Last Updated: 2021-08-23
Results Overview
Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter.
COMPLETED
PHASE2
40 participants
Baseline, Week 12
2021-08-23
Participant Flow
The study was conducted at two sites in the United States.
Eligible participants will be assigned in a random manner to 1 of the 2 study medications in a 2:1 ratio (ACU-D1 ointment: ACU-D1 ointment vehicle).
Participant milestones
| Measure |
ACU-D1 Ointment
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
13
|
|
Overall Study
COMPLETED
|
26
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
ACU-D1 Ointment
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea
Baseline characteristics by cohort
| Measure |
ACU-D1 Ointment
n=27 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.59 years
STANDARD_DEVIATION 11.537 • n=99 Participants
|
51.08 years
STANDARD_DEVIATION 12.473 • n=107 Participants
|
50.08 years
STANDARD_DEVIATION 11.708 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Total lesion count
|
18.00 number of lesions
STANDARD_DEVIATION 9.413 • n=99 Participants
|
20.46 number of lesions
STANDARD_DEVIATION 9.777 • n=107 Participants
|
18.80 number of lesions
STANDARD_DEVIATION 9.479 • n=206 Participants
|
|
Erythema score based on local tolerability as assessed by the investigator
Score 0 (clear)
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Erythema score based on local tolerability as assessed by the investigator
Score 1 (mild)
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Erythema score based on local tolerability as assessed by the investigator
Score 2 (moderate)
|
16 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Erythema score based on local tolerability as assessed by the investigator
Score 3 (severe)
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Number of participants included participants in the MITT population with available data at Week 12.
Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter.
Outcome measures
| Measure |
ACU-D1 Ointment
n=26 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=11 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Total Lesion Count at Week 12
|
-10.2 number of lesions
Standard Error 1.08
|
-12.0 number of lesions
Standard Error 1.62
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, and 12Population: MITT population. Number of participants analyzed included participants with available data at specific timepoint.
The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema
Outcome measures
| Measure |
ACU-D1 Ointment
n=27 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
Week 2
|
-23 percent change
Standard Deviation 0.2561
|
-29 percent change
Standard Deviation 0.1653
|
|
Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
Week 4
|
-35 percent change
Standard Deviation 0.2387
|
-26 percent change
Standard Deviation 0.2771
|
|
Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
Week 8
|
-31 percent change
Standard Deviation 0.2538
|
-29 percent change
Standard Deviation 0.2233
|
|
Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
Week 12
|
-31 percent change
Standard Deviation 0.2588
|
-26 percent change
Standard Deviation 0.3583
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: MITT population. Number of participants analyzed included participants with available IGA score at Week 12.
Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1. The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema
Outcome measures
| Measure |
ACU-D1 Ointment
n=26 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=11 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were Treatment Responders at Week 12
|
19.2 percentage of participants
|
18.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, and 12Population: MITT population. Number of participants analyzed included participants with available data at specified visits.
Papule - raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material
Outcome measures
| Measure |
ACU-D1 Ointment
n=27 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
Week 2
|
-6.6 number of lesions
Standard Error 1.09
|
-7.95 number of lesions
Standard Error 1.57
|
|
Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
Week 4
|
-9.7 number of lesions
Standard Error 0.97
|
-8.22 number of lesions
Standard Error 1.44
|
|
Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
Week 8
|
-8.1 number of lesions
Standard Error 1.16
|
-10.30 number of lesions
Standard Error 1.71
|
|
Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
Week 12
|
-9.2 number of lesions
Standard Error 1.01
|
-10.98 number of lesions
Standard Error 1.53
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, and 12Population: MITT population. Number of participants analyzed included participants with available data at specified visits.
Pustule - raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material
Outcome measures
| Measure |
ACU-D1 Ointment
n=27 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
Week 8
|
-1.1 number of lesions
Standard Error 0.25
|
-1.29 number of lesions
Standard Error 0.38
|
|
Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
Week 12
|
-1.0 number of lesions
Standard Error 0.31
|
-1.04 number of lesions
Standard Error 0.48
|
|
Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
Week 2
|
-0.4 number of lesions
Standard Error 0.43
|
-0.98 number of lesions
Standard Error 0.62
|
|
Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
Week 4
|
-1.2 number of lesions
Standard Error 0.20
|
-1.63 number of lesions
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, and 12Population: MITT population. Number of participants analyzed included participants with available data at specified visits.
Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter
Outcome measures
| Measure |
ACU-D1 Ointment
n=27 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
Week 2
|
0.0 number of lesions
Standard Error 0.04
|
0.02 number of lesions
Standard Error 0.06
|
|
Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
Week 4
|
0.0 number of lesions
Standard Error 0.04
|
-0.05 number of lesions
Standard Error 0.06
|
|
Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
Week 8
|
0.0 number of lesions
Standard Error 0.04
|
-0.05 number of lesions
Standard Error 0.06
|
|
Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
Week 12
|
0.0 number of lesions
Standard Error 0.04
|
0.04 number of lesions
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, and 12Population: MITT population. Number of participants analyzed included participants with available data at specified visits.
Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, \<0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, \<0.5 cm in diameter with visible purulent material) lesions.
Outcome measures
| Measure |
ACU-D1 Ointment
n=27 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
Week 2
|
-7.0 number of lesions
Standard Error 1.16
|
-8.97 number of lesions
Standard Error 1.67
|
|
Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
Week 8
|
-9.2 number of lesions
Standard Error 1.19
|
-11.65 number of lesions
Standard Error 1.75
|
|
Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
Week 4
|
-10.9 number of lesions
Standard Error 1.06
|
-9.90 number of lesions
Standard Error 1.57
|
|
Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
Week 12
|
-10.2 number of lesions
Standard Error 1.08
|
-12.03 number of lesions
Standard Error 1.62
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: Safety population included all randomized participants who received at least 1 dose of study medication.
Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs.
Outcome measures
| Measure |
ACU-D1 Ointment
n=27 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
11 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Safety population included all randomized participants who received at least 1 dose of study medication. Number of participants analyzed included participants with available data at specified timepoints.
Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema
Outcome measures
| Measure |
ACU-D1 Ointment
n=26 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=11 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12
Score 0 (clear)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12
Score 1 (mild)
|
14 Participants
|
3 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12
Score 2 (moderate)
|
9 Participants
|
6 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12
Score 3 (severe)
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Post-application) and Weeks 2, 4, 8, and 14Population: Safety population. Number of participants analyzed included participants with available data at specified timepoints.
Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema
Outcome measures
| Measure |
ACU-D1 Ointment
n=27 Participants
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 Participants
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Day 1 (Post-application) · Score 0 (clear)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Day 1 (Post-application) · Score 2 (moderate)
|
12 Participants
|
4 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 2 · Score 0 (clear)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 2 · Score 1 (mild)
|
12 Participants
|
7 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 2 · Score 2 (moderate)
|
12 Participants
|
4 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 2 · Score 3 (severe)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 4 · Score 1 (mild)
|
13 Participants
|
4 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 4 · Score 2 (moderate)
|
12 Participants
|
7 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 8 · Score 0 (clear)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 8 · Score 1 (mild)
|
11 Participants
|
5 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 8 · Score 2 (moderate)
|
13 Participants
|
6 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 8 · Score 3 (severe)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 14 · Score 0 (clear)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 14 · Score 1 (mild)
|
8 Participants
|
3 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 14 · Score 2 (moderate)
|
13 Participants
|
5 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 14 · Score 3 (severe)
|
3 Participants
|
3 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Day 1 (Post-application) · Score 1 (mild)
|
9 Participants
|
4 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Day 1 (Post-application) · Score 3 (severe)
|
5 Participants
|
4 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 4 · Score 0 (clear)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Week 4 · Score 3 (severe)
|
2 Participants
|
1 Participants
|
Adverse Events
ACU-D1 Ointment
ACU-D1 Ointment Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACU-D1 Ointment
n=27 participants at risk
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
|
ACU-D1 Ointment Vehicle
n=13 participants at risk
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
0.00%
0/13 • Baseline up to Week 14
Safety population
|
|
General disorders
Administration site dryness
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
7.7%
1/13 • Baseline up to Week 14
Safety population
|
|
General disorders
Administration site warmth
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
0.00%
0/13 • Baseline up to Week 14
Safety population
|
|
General disorders
Application site perspiration
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
0.00%
0/13 • Baseline up to Week 14
Safety population
|
|
Infections and infestations
Ear infection
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
0.00%
0/13 • Baseline up to Week 14
Safety population
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
2/27 • Baseline up to Week 14
Safety population
|
15.4%
2/13 • Baseline up to Week 14
Safety population
|
|
Infections and infestations
Respiratory tract infection
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
0.00%
0/13 • Baseline up to Week 14
Safety population
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
0.00%
0/13 • Baseline up to Week 14
Safety population
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
0.00%
0/13 • Baseline up to Week 14
Safety population
|
|
Investigations
White blood cell count decreased
|
0.00%
0/27 • Baseline up to Week 14
Safety population
|
7.7%
1/13 • Baseline up to Week 14
Safety population
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.7%
1/27 • Baseline up to Week 14
Safety population
|
0.00%
0/13 • Baseline up to Week 14
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27 • Baseline up to Week 14
Safety population
|
7.7%
1/13 • Baseline up to Week 14
Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place