Trial Outcomes & Findings for Safety and Efficacy of CD10367 in Psoriasis Vulgaris (NCT NCT03025282)
NCT ID: NCT03025282
Last Updated: 2024-09-19
Results Overview
The TSS is the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). Maximum total score was 12 (very severe); minimum total score was 0 (None). The mean AUC of TSSs were calculated for each intervention for all participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Day 1 to Day 19
Results posted on
2024-09-19
Participant Flow
The study was conducted at single center in France from 03-November-2016 to 24-March-2017.
A total of 29 participants were screened, of which 24 participants were enrolled and randomized to receive the study treatments on 6 target mini-zones (on upper and/or the lower extremities \[elbows, knees and tibiae shin area excluded\] and/or on the trunk).
Unit of analysis: mini-zones
Participant milestones
| Measure |
All Participants
Participants received 50 microliter (mcL) of 3 percent (3%) CD10367 solution and their matched placebo topically, on one or two desquamated psoriatic plaque (pre-treated) and 50 mcL of 3%, 1% CD10367 solution, their matched placebo and Betneval® 0.1% (positive control) topically, on one or two non-desquamated psoriatic plaque once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|
|
Overall Study
STARTED
|
24 144
|
|
Overall Study
COMPLETED
|
24 144
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of CD10367 in Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
All Participants
n=24 Participants
Participants received 50 mcL of 3% CD10367 solution or their matched placebo topically, on one or two desquamated psoriatic plaque (pre-treated) and 50 mcL of 3% and 1% CD10367 solution or their matched placebo and Betneval® 0.1% (positive control) topically, on one or two non-desquamated psoriatic plaque (pre-treated) once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 19Population: Analysis was performed on ITT population, which comprised of all participants who were randomized
The TSS is the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). Maximum total score was 12 (very severe); minimum total score was 0 (None). The mean AUC of TSSs were calculated for each intervention for all participants.
Outcome measures
| Measure |
CD10367 Placebo Pretreated
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 mini-zones
Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 mini-zones
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores)
|
103.4 score on a scale*days
Standard Deviation 24.5
|
101.7 score on a scale*days
Standard Deviation 22.5
|
118.0 score on a scale*days
Standard Deviation 23.2
|
118.6 score on a scale*days
Standard Deviation 24.0
|
116.6 score on a scale*days
Standard Deviation 26.3
|
75.3 score on a scale*days
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: Day 1 to Day 19Population: Analysis was performed on ITT population, which comprised all participants who were randomized
Each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) for each participant using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions. The mean AUC for each intervention was calculated for each participant.
Outcome measures
| Measure |
CD10367 Placebo Pretreated
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 mini-zones
Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 mini-zones
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of Individual Clinical Scores
Erythema
|
37.1 score on a scale*days
Standard Deviation 7.7
|
37.7 score on a scale*days
Standard Deviation 7.6
|
42.7 score on a scale*days
Standard Deviation 7.5
|
41.3 score on a scale*days
Standard Deviation 7.7
|
41.7 score on a scale*days
Standard Deviation 8.6
|
27.2 score on a scale*days
Standard Deviation 7.4
|
|
Area Under the Curve (AUC) of Individual Clinical Scores
Scaling
|
32.3 score on a scale*days
Standard Deviation 12.8
|
31.1 score on a scale*days
Standard Deviation 11.3
|
38.4 score on a scale*days
Standard Deviation 11.0
|
40.2 score on a scale*days
Standard Deviation 11.8
|
39.6 score on a scale*days
Standard Deviation 12.6
|
20.5 score on a scale*days
Standard Deviation 4.9
|
|
Area Under the Curve (AUC) of Individual Clinical Scores
Induration
|
34.0 score on a scale*days
Standard Deviation 5.6
|
32.9 score on a scale*days
Standard Deviation 6.2
|
36.9 score on a scale*days
Standard Deviation 7.2
|
37.1 score on a scale*days
Standard Deviation 7.0
|
35.3 score on a scale*days
Standard Deviation 7.8
|
27.5 score on a scale*days
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19Population: Analysis was performed on ITT population, which comprised all participants who were randomized.
The TSS was the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). where maximum total score was 12 (worst condition) and minimum total score was 0 (no symptoms).
Outcome measures
| Measure |
CD10367 Placebo Pretreated
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 mini-zones
Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 mini-zones
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Total Sum Score (TSS) of Individual Clinical Scores
Day 1
|
5.0 score on a scale
Standard Deviation 0.3
|
5.0 score on a scale
Standard Deviation 0.3
|
7.3 score on a scale
Standard Deviation 1.0
|
7.3 score on a scale
Standard Deviation 1.0
|
7.3 score on a scale
Standard Deviation 1.0
|
7.2 score on a scale
Standard Deviation 1.0
|
|
Total Sum Score (TSS) of Individual Clinical Scores
Day 4
|
5.5 score on a scale
Standard Deviation 1.1
|
5.6 score on a scale
Standard Deviation 1.3
|
6.8 score on a scale
Standard Deviation 1.3
|
6.7 score on a scale
Standard Deviation 1.4
|
6.8 score on a scale
Standard Deviation 1.3
|
4.5 score on a scale
Standard Deviation 1.2
|
|
Total Sum Score (TSS) of Individual Clinical Scores
Day 8
|
6.4 score on a scale
Standard Deviation 1.4
|
6.2 score on a scale
Standard Deviation 1.4
|
7.1 score on a scale
Standard Deviation 1.3
|
6.8 score on a scale
Standard Deviation 1.8
|
6.8 score on a scale
Standard Deviation 1.9
|
4.5 score on a scale
Standard Deviation 1.1
|
|
Total Sum Score (TSS) of Individual Clinical Scores
Day 11
|
5.8 score on a scale
Standard Deviation 1.6
|
5.8 score on a scale
Standard Deviation 1.8
|
6.0 score on a scale
Standard Deviation 1.7
|
6.4 score on a scale
Standard Deviation 1.8
|
6.1 score on a scale
Standard Deviation 2.1
|
3.5 score on a scale
Standard Deviation 1.1
|
|
Total Sum Score (TSS) of Individual Clinical Scores
Day 15
|
5.9 score on a scale
Standard Deviation 2.1
|
5.8 score on a scale
Standard Deviation 1.8
|
6.5 score on a scale
Standard Deviation 1.9
|
6.7 score on a scale
Standard Deviation 1.6
|
6.5 score on a scale
Standard Deviation 1.6
|
3.7 score on a scale
Standard Deviation 1.2
|
|
Total Sum Score (TSS) of Individual Clinical Scores
Day 19
|
5.2 score on a scale
Standard Deviation 2.3
|
4.8 score on a scale
Standard Deviation 1.5
|
5.7 score on a scale
Standard Deviation 1.5
|
5.7 score on a scale
Standard Deviation 1.7
|
5.5 score on a scale
Standard Deviation 1.9
|
3.0 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19Population: Analysis was performed on ITT population, which comprised all participants who were randomized.
The TSS was the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). where maximum score was 12 (worst condition) and minimum score was 0 (no symptoms). The TSS percentage change from Day 1 at each visit and erythema, scaling and induration scores and their changes from Day 1 at each visit were evaluated by visit and by treatment received.
Outcome measures
| Measure |
CD10367 Placebo Pretreated
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 mini-zones
Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 mini-zones
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Percent Change in Total Sum Score (TSS)
Day 19
|
3.4 percent change
Standard Deviation 43.3
|
-5.8 percent change
Standard Deviation 25.5
|
-22.3 percent change
Standard Deviation 18.0
|
-22.0 percent change
Standard Deviation 19.4
|
-26.6 percent change
Standard Deviation 19.1
|
-58.4 percent change
Standard Deviation 16.6
|
|
Percent Change in Total Sum Score (TSS)
Day 4
|
9.7 percent change
Standard Deviation 20.0
|
11.6 percent change
Standard Deviation 24.1
|
-7.3 percent change
Standard Deviation 11.4
|
-7.4 percent change
Standard Deviation 14.7
|
-7.8 percent change
Standard Deviation 13.0
|
-36.6 percent change
Standard Deviation 13.3
|
|
Percent Change in Total Sum Score (TSS)
Day 8
|
28.3 percent change
Standard Deviation 26.8
|
24.1 percent change
Standard Deviation 25.5
|
-2.9 percent change
Standard Deviation 11.0
|
-6.1 percent change
Standard Deviation 17.7
|
-8.5 percent change
Standard Deviation 20.6
|
-36.9 percent change
Standard Deviation 14.1
|
|
Percent Change in Total Sum Score (TSS)
Day 11
|
15.0 percent change
Standard Deviation 30.6
|
16.1 percent change
Standard Deviation 32.2
|
-17.4 percent change
Standard Deviation 20.3
|
-12.2 percent change
Standard Deviation 21.2
|
-17.0 percent change
Standard Deviation 22.7
|
-51.9 percent change
Standard Deviation 13.2
|
|
Percent Change in Total Sum Score (TSS)
Day 15
|
17.6 percent change
Standard Deviation 38.5
|
14.4 percent change
Standard Deviation 31.4
|
-11.7 percent change
Standard Deviation 21.9
|
-7.4 percent change
Standard Deviation 21.4
|
-11.7 percent change
Standard Deviation 17.2
|
-48.1 percent change
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19Population: Analysis was performed on ITT population, which comprised all participants who were randomized
Status of psoriasis for each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions.
Outcome measures
| Measure |
CD10367 Placebo Pretreated
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 mini-zones
Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 mini-zones
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Erythema, Scaling and Induration Scores at Each Visit
Induration: Day 4
|
2.0 score on scale
Standard Deviation 0.2
|
1.9 score on scale
Standard Deviation 0.3
|
2.1 score on scale
Standard Deviation 0.3
|
2.0 score on scale
Standard Deviation 0.4
|
2.1 score on scale
Standard Deviation 0.4
|
1.8 score on scale
Standard Deviation 0.4
|
|
Erythema, Scaling and Induration Scores at Each Visit
Induration: Day 8
|
2.0 score on scale
Standard Deviation 0.3
|
1.9 score on scale
Standard Deviation 0.4
|
2.2 score on scale
Standard Deviation 0.4
|
2.2 score on scale
Standard Deviation 0.5
|
2.0 score on scale
Standard Deviation 0.6
|
1.7 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Induration: Day 11
|
1.8 score on scale
Standard Deviation 0.5
|
1.7 score on scale
Standard Deviation 0.6
|
1.8 score on scale
Standard Deviation 0.6
|
2.0 score on scale
Standard Deviation 0.6
|
1.8 score on scale
Standard Deviation 0.7
|
1.3 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Induration: Day 15
|
1.9 score on scale
Standard Deviation 0.6
|
1.8 score on scale
Standard Deviation 0.6
|
2.1 score on scale
Standard Deviation 0.6
|
2.1 score on scale
Standard Deviation 0.5
|
2.0 score on scale
Standard Deviation 0.6
|
1.3 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Induration: Day 19
|
1.6 score on scale
Standard Deviation 0.8
|
1.6 score on scale
Standard Deviation 0.6
|
1.9 score on scale
Standard Deviation 0.5
|
1.9 score on scale
Standard Deviation 0.5
|
1.8 score on scale
Standard Deviation 0.7
|
1.1 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Erythema: Day 1
|
2.0 score on scale
Standard Deviation 0.2
|
2.0 score on scale
Standard Deviation 0.2
|
2.6 score on scale
Standard Deviation 0.5
|
2.5 score on scale
Standard Deviation 0.5
|
2.6 score on scale
Standard Deviation 0.5
|
2.5 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Erythema: Day 4
|
2.0 score on scale
Standard Deviation 0.4
|
2.1 score on scale
Standard Deviation 0.5
|
2.5 score on scale
Standard Deviation 0.6
|
2.4 score on scale
Standard Deviation 0.7
|
2.3 score on scale
Standard Deviation 0.6
|
1.5 score on scale
Standard Deviation 0.6
|
|
Erythema, Scaling and Induration Scores at Each Visit
Erythema: Day 8
|
2.3 score on scale
Standard Deviation 0.6
|
2.3 score on scale
Standard Deviation 0.5
|
2.5 score on scale
Standard Deviation 0.6
|
2.3 score on scale
Standard Deviation 0.6
|
2.4 score on scale
Standard Deviation 0.7
|
1.5 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Erythema: Day 11
|
2.0 score on scale
Standard Deviation 0.5
|
2.1 score on scale
Standard Deviation 0.6
|
2.3 score on scale
Standard Deviation 0.5
|
2.2 score on scale
Standard Deviation 0.7
|
2.2 score on scale
Standard Deviation 0.7
|
1.3 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Erythema: Day 15
|
2.0 score on scale
Standard Deviation 0.7
|
2.1 score on scale
Standard Deviation 0.6
|
2.3 score on scale
Standard Deviation 0.6
|
2.3 score on scale
Standard Deviation 0.5
|
2.4 score on scale
Standard Deviation 0.6
|
1.4 score on scale
Standard Deviation 0.6
|
|
Erythema, Scaling and Induration Scores at Each Visit
Erythema: Day 19
|
1.9 score on scale
Standard Deviation 0.7
|
1.8 score on scale
Standard Deviation 0.5
|
2.0 score on scale
Standard Deviation 0.6
|
2.1 score on scale
Standard Deviation 0.4
|
2.0 score on scale
Standard Deviation 0.6
|
1.1 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Scaling: Day 1
|
1.0 score on scale
Standard Deviation 0.2
|
1.0 score on scale
Standard Deviation 0.2
|
2.5 score on scale
Standard Deviation 0.5
|
2.5 score on scale
Standard Deviation 0.5
|
2.6 score on scale
Standard Deviation 0.5
|
2.5 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Scaling: Day 4
|
1.5 score on scale
Standard Deviation 0.7
|
1.5 score on scale
Standard Deviation 0.8
|
2.2 score on scale
Standard Deviation 0.6
|
2.3 score on scale
Standard Deviation 0.7
|
2.4 score on scale
Standard Deviation 0.6
|
1.2 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Scaling: Day 8
|
2.1 score on scale
Standard Deviation 0.8
|
2.0 score on scale
Standard Deviation 0.8
|
2.4 score on scale
Standard Deviation 0.7
|
2.3 score on scale
Standard Deviation 0.9
|
2.3 score on scale
Standard Deviation 1.0
|
1.3 score on scale
Standard Deviation 0.4
|
|
Erythema, Scaling and Induration Scores at Each Visit
Scaling: Day 11
|
1.9 score on scale
Standard Deviation 0.9
|
2.0 score on scale
Standard Deviation 0.9
|
2.0 score on scale
Standard Deviation 0.8
|
2.2 score on scale
Standard Deviation 0.9
|
2.1 score on scale
Standard Deviation 1.1
|
0.8 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Scaling: Day 15
|
2.0 score on scale
Standard Deviation 1.0
|
1.8 score on scale
Standard Deviation 0.9
|
2.0 score on scale
Standard Deviation 0.9
|
2.3 score on scale
Standard Deviation 0.9
|
2.1 score on scale
Standard Deviation 0.9
|
1.0 score on scale
Standard Deviation 0.4
|
|
Erythema, Scaling and Induration Scores at Each Visit
Scaling: Day 19
|
1.7 score on scale
Standard Deviation 1.0
|
1.4 score on scale
Standard Deviation 0.6
|
1.7 score on scale
Standard Deviation 0.8
|
1.7 score on scale
Standard Deviation 1.0
|
1.7 score on scale
Standard Deviation 0.8
|
0.7 score on scale
Standard Deviation 0.5
|
|
Erythema, Scaling and Induration Scores at Each Visit
Induration: Day 1
|
2.0 score on scale
Standard Deviation 0.0
|
2.0 score on scale
Standard Deviation 0.0
|
2.2 score on scale
Standard Deviation 0.4
|
2.2 score on scale
Standard Deviation 0.4
|
2.1 score on scale
Standard Deviation 0.3
|
2.1 score on scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Day 1, Day 4, Day 8, Day 11, Day 15, Day 19Population: Analysis was performed on ITT population, which comprised all participants who were randomized
Status of psoriasis for each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions.
Outcome measures
| Measure |
CD10367 Placebo Pretreated
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 mini-zones
Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 mini-zones
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Erythema: Day 4
|
-0.0 percent change
Standard Deviation 0.4
|
0.1 percent change
Standard Deviation 0.5
|
-0.1 percent change
Standard Deviation 0.4
|
-0.1 percent change
Standard Deviation 0.4
|
-3.0 percent change
Standard Deviation 0.5
|
-1.0 percent change
Standard Deviation 0.6
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Erythema: Day 8
|
0.3 percent change
Standard Deviation 0.5
|
0.2 percent change
Standard Deviation 0.5
|
-0.1 percent change
Standard Deviation 0.4
|
-0.2 percent change
Standard Deviation 0.5
|
-0.2 percent change
Standard Deviation 0.6
|
-1.0 percent change
Standard Deviation 0.4
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Erythema: Day 11
|
0.0 percent change
Standard Deviation 0.4
|
0.1 percent change
Standard Deviation 0.6
|
-0.4 percent change
Standard Deviation 0.7
|
-0.3 percent change
Standard Deviation 0.8
|
-0.4 percent change
Standard Deviation 0.8
|
-1.2 percent change
Standard Deviation 0.6
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Erythema: Day 15
|
-0.0 percent change
Standard Deviation 0.6
|
-0.0 percent change
Standard Deviation 0.6
|
-0.3 percent change
Standard Deviation 0.7
|
-0.3 percent change
Standard Deviation 0.6
|
-0.2 percent change
Standard Deviation 0.7
|
-1.1 percent change
Standard Deviation 0.7
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Erythema: Day 19
|
-0.1 percent change
Standard Deviation 0.7
|
-0.3 percent change
Standard Deviation 0.4
|
-0.6 percent change
Standard Deviation 0.8
|
-0.5 percent change
Standard Deviation 0.5
|
-0.7 percent change
Standard Deviation 0.6
|
-1.4 percent change
Standard Deviation 0.7
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Scaling: Day 4
|
0.6 percent change
Standard Deviation 0.7
|
0.6 percent change
Standard Deviation 0.8
|
-0.4 percent change
Standard Deviation 0.6
|
-0.3 percent change
Standard Deviation 0.8
|
-0.2 percent change
Standard Deviation 0.5
|
-1.3 percent change
Standard Deviation 0.6
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Scaling: Day 8
|
1.2 percent change
Standard Deviation 0.8
|
1.1 percent change
Standard Deviation 0.7
|
-0.1 percent change
Standard Deviation 0.5
|
-0.2 percent change
Standard Deviation 0.9
|
-0.3 percent change
Standard Deviation 1.0
|
-1.3 percent change
Standard Deviation 0.6
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Scaling: Day 11
|
1.0 percent change
Standard Deviation 1.0
|
1.0 percent change
Standard Deviation 0.9
|
-0.5 percent change
Standard Deviation 0.8
|
-0.3 percent change
Standard Deviation 1.0
|
-0.5 percent change
Standard Deviation 1.0
|
-1.7 percent change
Standard Deviation 0.6
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Scaling: Day 15
|
1.0 percent change
Standard Deviation 1.0
|
0.9 percent change
Standard Deviation 0.9
|
-0.5 percent change
Standard Deviation 0.8
|
-0.3 percent change
Standard Deviation 0.9
|
-0.5 percent change
Standard Deviation 0.7
|
-1.5 percent change
Standard Deviation 0.6
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Scaling: Day 19
|
0.7 percent change
Standard Deviation 1.0
|
0.4 percent change
Standard Deviation 0.6
|
-0.8 percent change
Standard Deviation 0.8
|
-0.8 percent change
Standard Deviation 1.0
|
-0.9 percent change
Standard Deviation 0.6
|
-1.8 percent change
Standard Deviation 0.7
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Induration: Day 4
|
-0.0 percent change
Standard Deviation 0.2
|
-0.1 percent change
Standard Deviation 0.3
|
-0.0 percent change
Standard Deviation 0.2
|
-0.1 percent change
Standard Deviation 0.3
|
-0.0 percent change
Standard Deviation 0.4
|
-0.3 percent change
Standard Deviation 0.5
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Induration: Day 8
|
0.0 percent change
Standard Deviation 0.3
|
-0.1 percent change
Standard Deviation 0.4
|
0.0 percent change
Standard Deviation 0.3
|
0.0 percent change
Standard Deviation 0.3
|
-0.1 percent change
Standard Deviation 0.4
|
-0.4 percent change
Standard Deviation 0.5
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Induration: Day 11
|
-0.2 percent change
Standard Deviation 0.5
|
-0.3 percent change
Standard Deviation 0.6
|
-0.4 percent change
Standard Deviation 0.5
|
-0.2 percent change
Standard Deviation 0.4
|
-0.3 percent change
Standard Deviation 0.6
|
-0.8 percent change
Standard Deviation 0.4
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Induration: Day 15
|
-0.1 percent change
Standard Deviation 0.6
|
-0.2 percent change
Standard Deviation 0.6
|
-0.0 percent change
Standard Deviation 0.6
|
-0.0 percent change
Standard Deviation 0.5
|
-0.2 percent change
Standard Deviation 0.5
|
-0.8 percent change
Standard Deviation 0.4
|
|
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Induration: Day 19
|
-0.4 percent change
Standard Deviation 0.8
|
-0.4 percent change
Standard Deviation 0.6
|
-0.3 percent change
Standard Deviation 0.4
|
-0.3 percent change
Standard Deviation 0.5
|
-0.3 percent change
Standard Deviation 0.6
|
-0.1 percent change
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day 4, Day 8, Day 11, Day 15 and Day 19Population: Analysis was performed on ITT population, which comprised all participants who were randomized.
Success rate was defined as a clearing score of 0 or 1, at each evaluation visit (Day 4, Day 8, Day 11, Day 15 and Day 19). The clearing score was ranged from 0 to 2, where scores were indicated as follows: 0=complete clearing (no scaling and no infiltration even on palpation. Post inflammatory hypo- or hyperpigmentation might be present, 1=almost clear (Residual erythema with some induration/infiltration \[not clinically visible but palpable\] without scaling, or residual erythema and residual scaling with no infiltration, 2=unchanged (unchanged or less than almost clear). Higher score indicated less success in clearing condition (worse outcome).
Outcome measures
| Measure |
CD10367 Placebo Pretreated
n=24 Participants
Participants received 50 mcL of matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 Participants
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 Participants
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 Participants
Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 Participants
Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 Participants
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Success Rate at Each Visit
Day 19: Yes
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 19: No
|
23 Participants
|
23 Participants
|
24 Participants
|
23 Participants
|
23 Participants
|
17 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 4: Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 4: No
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 8: Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 8: No
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 11: Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 11: No
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
19 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 15: Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Success Rate at Each Visit
Day 15: No
|
23 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 19Population: Analysis was performed on ITT population, which comprised all participants who were randomized.
The time to first success was defined as 0=no Success at any day, 1=success at Day 19 and not before, 2=success at Day 15 and not before, 3=success at Day 11 and not before, where lower score indicated less success in clearing condition (worse outcome).
Outcome measures
| Measure |
CD10367 Placebo Pretreated
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 mini-zones
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 mini-zones
Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 mini-zones
Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 mini-zones
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Time to First Success
0-No success at any day
|
23 mini-zones
|
23 mini-zones
|
24 mini-zones
|
23 mini-zones
|
23 mini-zones
|
15 mini-zones
|
|
Time to First Success
1-Success at Day 19 and not before
|
0 mini-zones
|
1 mini-zones
|
0 mini-zones
|
1 mini-zones
|
1 mini-zones
|
4 mini-zones
|
|
Time to First Success
2-Success at Day 15 and not before
|
1 mini-zones
|
0 mini-zones
|
0 mini-zones
|
0 mini-zones
|
0 mini-zones
|
0 mini-zones
|
|
Time to First Success
3-Success at Day 11 and not before
|
0 mini-zones
|
0 mini-zones
|
0 mini-zones
|
0 mini-zones
|
0 mini-zones
|
5 mini-zones
|
Adverse Events
CD10367 Placebo Pretreated
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CD10367 3% Pretreated
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CD10367 Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CD10367 1%
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CD10367 3%
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Betneval 0.1%
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 |
CD10367 Placebo Pretreated
n=24 participants at risk
Participants received 50 mcL matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3% Pretreated
n=24 participants at risk
Participants received 50 mcL 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 Placebo
n=24 participants at risk
Participants received matched placebo 50 mcL solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 1%
n=24 participants at risk
Participants received 50 mcL 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
CD10367 3%
n=24 participants at risk
Participants received 50 mcL 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
Betneval 0.1%
n=24 participants at risk
Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
8.3%
2/24 • Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place