Trial Outcomes & Findings for To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin (NCT NCT03467412)
NCT ID: NCT03467412
Last Updated: 2020-12-03
Results Overview
Change from baseline of total hair density (No. of hairs per cm"2") on the scalp
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-12-03
Participant Flow
Each subject received 2 dose strengths on 2 separate areas locally applied on the scalp. Thus, 120 treatment areas were defined in the trial but only 60 subjects participated. The number of participants in each arms are not unique subjects since each subject will appear in 2 arms. The total number of participants in the trial is 60.
Unit of analysis: Treatment area on scalp
Participant milestones
| Measure |
0.00625 μg FOL-005
50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.025 μg FOL-005
50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.050 μg FOL-005
50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.100 μg FOL-005
50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
Placebo
50 μl solution (placebo) injected intradermally three times per week for 12 weeks.
Placebo: intradermal injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25 25
|
25 25
|
25 25
|
25 25
|
20 20
|
|
Overall Study
COMPLETED
|
22 22
|
24 24
|
20 20
|
23 23
|
17 17
|
|
Overall Study
NOT COMPLETED
|
3 3
|
1 1
|
5 5
|
2 2
|
3 3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin
Baseline characteristics by cohort
| Measure |
Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment
n=120 Areas on the scalp
In total 60 subjects were recruited. Each subject received 2 treatments in parallell on 2 different treatment areas. Baseline characteristics can therefore not be described for the individual treatment groups as they refer to treatment areas and not subjects. Hence, baseline characteristics are only reported for the total number of recruited subjects, i.e. 60.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 9.8 • n=60 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=60 Participants
|
|
Region of Enrollment
Germany
|
60 participants
n=60 Participants
|
|
Weight
|
84.91 kg
STANDARD_DEVIATION 14.88 • n=60 Participants
|
|
Height
|
180.6 cm
STANDARD_DEVIATION 6.7 • n=60 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Note: one subject receiving 0.00625 and 0.050 μg FOL-005 withdrew consent after treatment. Data for primary outcome were available and and consequently used. The nNumber of analysed subjects therefore exceeds number of completed subjects.
Change from baseline of total hair density (No. of hairs per cm"2") on the scalp
Outcome measures
| Measure |
0.00625 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.025 μg FOL-005
n=24 Participants
50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.050 μg FOL-005
n=21 Participants
50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.100 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
Placebo
n=17 Participants
50 μl solution (placebo) injected intradermally three times per week for 12 weeks.
Placebo: intradermal injection
|
|---|---|---|---|---|---|
|
Scalp Hair Density
|
1.46 Change from baseline (No. of hairs/cm2)
Standard Deviation 14.75
|
2.58 Change from baseline (No. of hairs/cm2)
Standard Deviation 15.36
|
-4.10 Change from baseline (No. of hairs/cm2)
Standard Deviation 21.00
|
6.68 Change from baseline (No. of hairs/cm2)
Standard Deviation 22.24
|
5.60 Change from baseline (No. of hairs/cm2)
Standard Deviation 16.71
|
SECONDARY outcome
Timeframe: From baseline to after 12 weeks treatmentChange from baseline in proportion of anagen hairs (%) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)
Outcome measures
| Measure |
0.00625 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.025 μg FOL-005
n=24 Participants
50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.050 μg FOL-005
n=21 Participants
50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.100 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
Placebo
n=17 Participants
50 μl solution (placebo) injected intradermally three times per week for 12 weeks.
Placebo: intradermal injection
|
|---|---|---|---|---|---|
|
Proportion of Anagen Hairs (%)
|
-0.03 percentage of anagen hairs
Standard Deviation 15.68
|
1.40 percentage of anagen hairs
Standard Deviation 11.43
|
-0.73 percentage of anagen hairs
Standard Deviation 14.23
|
3.18 percentage of anagen hairs
Standard Deviation 15.16
|
-3.08 percentage of anagen hairs
Standard Deviation 9.53
|
SECONDARY outcome
Timeframe: From baseline to after 12 weeks treatmentChange from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of
Outcome measures
| Measure |
0.00625 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.025 μg FOL-005
n=24 Participants
50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.050 μg FOL-005
n=21 Participants
50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.100 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
Placebo
n=17 Participants
50 μl solution (placebo) injected intradermally three times per week for 12 weeks.
Placebo: intradermal injection
|
|---|---|---|---|---|---|
|
Change in Proportion of Telogen Hairs (%)
|
8.49 percentage of telogen hairs
Standard Deviation 31.36
|
-0.05 percentage of telogen hairs
Standard Deviation 22.12
|
8.66 percentage of telogen hairs
Standard Deviation 34.71
|
2.21 percentage of telogen hairs
Standard Deviation 36.82
|
14.60 percentage of telogen hairs
Standard Deviation 25.58
|
SECONDARY outcome
Timeframe: From baseline to after 12 weeks treatmentChange from baseline of anagen hair density (number of hairs per cm"2") on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.
Outcome measures
| Measure |
0.00625 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.025 μg FOL-005
n=24 Participants
50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.050 μg FOL-005
n=21 Participants
50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.100 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
Placebo
n=17 Participants
50 μl solution (placebo) injected intradermally three times per week for 12 weeks.
Placebo: intradermal injection
|
|---|---|---|---|---|---|
|
Anagen Hair Density
|
-2.26 number of hairs per cm2
Standard Deviation 28.89
|
3.65 number of hairs per cm2
Standard Deviation 21.77
|
-4.41 number of hairs per cm2
Standard Deviation 24.85
|
5.79 number of hairs per cm2
Standard Deviation 25.21
|
-2.31 number of hairs per cm2
Standard Deviation 19.70
|
SECONDARY outcome
Timeframe: From baseline to after 12 weeks treatmentChange from baseline of telogen hair density (number of hairs per cm2) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)
Outcome measures
| Measure |
0.00625 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.025 μg FOL-005
n=24 Participants
50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.050 μg FOL-005
n=21 Participants
50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.100 μg FOL-005
n=23 Participants
50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.
FOL-005: intradermal injection
|
Placebo
n=17 Participants
50 μl solution (placebo) injected intradermally three times per week for 12 weeks.
Placebo: intradermal injection
|
|---|---|---|---|---|---|
|
Change in Telogen Hair Density
|
3.72 number of hairs per cm2
Standard Deviation 18.65
|
-1.06 number of hairs per cm2
Standard Deviation 16.33
|
0.31 number of hairs per cm2
Standard Deviation 16.39
|
0.89 number of hairs per cm2
Standard Deviation 22.15
|
7.91 number of hairs per cm2
Standard Deviation 14.34
|
Adverse Events
Systemic Adverse Events
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
0.100 μg FOL-005
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.00625 μg FOL-005
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.025 μg FOL-005
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
0.050 μg FOL-005
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Systemic Adverse Events
n=60 participants at risk
The systemic (or non-local) AEs are reported for the whole group (60 subjects) only. these events can not be related to one dose strengthe since all subjects received more than one dose.
Dose range for this group range from 0.0065 μg (subjects receiving a combination of the lowest dose and placebo) to 0.150 μg (subjects receiving a combination of the 2 highest doses)
|
0.100 μg FOL-005
n=25 participants at risk
0.100 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.
FOL-005: intradermal injection
|
Placebo
n=20 participants at risk
Placebo. 50 μl injected sub-cutaneous three times per week for 12 weeks.
Placebo: intradermal injection
|
0.00625 μg FOL-005
n=25 participants at risk
0.00625 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.025 μg FOL-005
n=25 participants at risk
0.025 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.
FOL-005: intradermal injection
|
0.050 μg FOL-005
n=25 participants at risk
0.050 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.
FOL-005: intradermal injection
|
|---|---|---|---|---|---|---|
|
General disorders
Application site eczema
|
0.00%
0/60 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
4.0%
1/25 • Number of events 2 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
General disorders
Application site exfoliation
|
0.00%
0/60 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
8.0%
2/25 • Number of events 2 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
4.0%
1/25 • Number of events 1 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
8.0%
2/25 • Number of events 2 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
8.0%
2/25 • Number of events 2 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
Infections and infestations
Application site pustules
|
0.00%
0/60 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
4.0%
1/25 • Number of events 1 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
4.0%
1/25 • Number of events 1 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/60 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
4.0%
1/25 • Number of events 1 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
Infections and infestations
Rash pustular
|
6.7%
4/60 • Number of events 4 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/60 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
4.0%
1/25 • Number of events 1 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/60 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
16.0%
4/25 • Number of events 5 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
20.0%
4/20 • Number of events 4 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
12.0%
3/25 • Number of events 4 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
12.0%
3/25 • Number of events 3 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
4.0%
1/25 • Number of events 1 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
3/60 • Number of events 4 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
10/60 • Number of events 10 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
Nervous system disorders
Headache
|
8.3%
5/60 • Number of events 10 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
|
General disorders
Influenza like illness
|
8.3%
5/60 • Number of events 5 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/20 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
0.00%
0/25 • 12 weeks
Only local adverse events are reported by treatment arm. Systemic adverse events can not be reported by treatment since subjects received two treatments each. These have been reported in a separate group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place