Trial Outcomes & Findings for Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation (NCT NCT04856904)
NCT ID: NCT04856904
Last Updated: 2024-06-11
Results Overview
The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2024-06-11
Participant Flow
The study was conducted at 20 sites in the United States, Canada, and France.
A total 121 participants were enrolled in this study. All participants were randomized (left face versus right face) to apply trifarotene cream and trifarotene vehicle cream for an intra-individual, split-face comparison.
Unit of analysis: half faces
Participant milestones
| Measure |
Trifarotene 50mcg/g Cream
Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.
|
Trifarotene Vehicle Cream
Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
121 121
|
121 121
|
|
Overall Study
COMPLETED
|
99 99
|
99 99
|
|
Overall Study
NOT COMPLETED
|
22 22
|
22 22
|
Reasons for withdrawal
| Measure |
Trifarotene 50mcg/g Cream
Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.
|
Trifarotene Vehicle Cream
Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Non-compliance with study drug
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
Baseline characteristics by cohort
| Measure |
All Acne Vulgaris Participants
n=121 Participants
All participants applied a thin layer of trifarotene 50 mcg/g cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.
|
|---|---|
|
Age, Continuous
|
22.9 years
STANDARD_DEVIATION 5.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 count of participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 count of participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 count of participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type I
|
7 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type II
|
43 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type III
|
31 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
26 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type V
|
11 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all randomized participants.
The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
Outcome measures
| Measure |
Trifarotene 50mcg/g Cream
n=121 Participants
Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.
|
Trifarotene Vehicle Cream
n=121 Participants
Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24
|
-5.9 atrophic acne scars
Standard Error 0.51
|
-2.7 atrophic acne scars
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline, up to Week 20Population: ITT population included all randomized participants.
The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
Outcome measures
| Measure |
Trifarotene 50mcg/g Cream
n=121 Participants
Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.
|
Trifarotene Vehicle Cream
n=121 Participants
Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
Change at Week 1
|
-0.3 atrophic acne scars
Standard Error 0.21
|
-0.3 atrophic acne scars
Standard Error 0.16
|
|
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
Change at Week 2
|
-0.9 atrophic acne scars
Standard Error 0.26
|
-0.4 atrophic acne scars
Standard Error 0.11
|
|
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
Change at Week 4
|
-1.5 atrophic acne scars
Standard Error 0.27
|
-0.7 atrophic acne scars
Standard Error 0.18
|
|
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
Change at Week 8
|
-2.5 atrophic acne scars
Standard Error 0.30
|
-1.1 atrophic acne scars
Standard Error 0.30
|
|
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
Change at Week 12
|
-3.8 atrophic acne scars
Standard Error 0.37
|
-1.7 atrophic acne scars
Standard Error 0.32
|
|
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
Change at Week 16
|
-4.4 atrophic acne scars
Standard Error 0.40
|
-1.7 atrophic acne scars
Standard Error 0.47
|
|
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20
Change at Week 20
|
-5.0 atrophic acne scars
Standard Error 0.47
|
-2.5 atrophic acne scars
Standard Error 0.33
|
Adverse Events
Trifarotene 50mcg/g Cream
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Trifarotene Vehicle Cream
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
All Acne Vulgaris Participants
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trifarotene 50mcg/g Cream
n=121 participants at risk
Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.
|
Trifarotene Vehicle Cream
n=121 participants at risk
Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.
|
All Acne Vulgaris Participants
n=121 participants at risk
All participants applied a thin layer of trifarotene 50 mcg/g cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
8.3%
10/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
1.7%
2/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Infections and infestations
Viral infection
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
1.7%
2/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
1.7%
2/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
1.7%
2/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
1.7%
2/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
1.7%
2/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
General disorders
Adverse reaction
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
General disorders
Face oedema
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
General disorders
Influenza like illness
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
General disorders
Vaccination site pain
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Nervous system disorders
Burning sensation
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Nervous system disorders
Headache
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
1.7%
2/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Immune system disorders
Food allergy
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.00%
0/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
0.83%
1/121 • From screening up to Week 28
The safety (SAF) population included the ITT population participants who applied the study drug at least once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER