Trial Outcomes & Findings for Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne (NCT NCT02575950)
NCT ID: NCT02575950
Last Updated: 2025-03-06
Results Overview
Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
At Week 12 (Day 84)
Results posted on
2025-03-06
Participant Flow
19 of the participants enrolled were screening failures. The remaining 40 were enrolled sequentially into 4 cohorts. Progression from one cohort to the next was decided by the Safety Review Committee following a review of local skin responses (LSRs), safety, and tolerability after the last participant in each cohort had completed the Week 2 visit.
Participant milestones
| Measure |
Cohort 1
Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas (approx. 36 cm2 each) sequentially so that the second and third participants were not dosed until a safety evaluation of the preceding participant had been done. The first participant was dosed for 1 day, the second participant for up to 2 days, and the third participant for up to 3 days.
|
Cohort 2
Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
|
Cohort 3
Participants received once daily treatment with LEO 43204 gel 0.018 and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
|
Cohort 4
Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
25
|
|
Overall Study
COMPLETED
|
3
|
5
|
6
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
5
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas (approx. 36 cm2 each) sequentially so that the second and third participants were not dosed until a safety evaluation of the preceding participant had been done. The first participant was dosed for 1 day, the second participant for up to 2 days, and the third participant for up to 3 days.
|
Cohort 2
Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
|
Cohort 3
Participants received once daily treatment with LEO 43204 gel 0.018 and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
|
Cohort 4
Participants received once daily treatment with LEO 43204 gel 0.018% and LEO 43204 gel vehicle on either left or right cheek acne lesion areas of approximately 36 cm2 each for 3 days with Days 2 and 3 optional.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
3
|
Baseline Characteristics
Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne
Baseline characteristics by cohort
| Measure |
Total
n=40 Participants
All participants randomized to treatment
|
|---|---|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 3.8 • n=99 Participants
|
|
Age, Customized
Years · 18-20
|
18 Participants
n=99 Participants
|
|
Age, Customized
Years · 21-24
|
16 Participants
n=99 Participants
|
|
Age, Customized
Years · 25-35
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At Week 12 (Day 84)Population: The analysis was based on the full analysis set (FAS). At Week 12, FAS comprised 32 subjects as 6 subjects discontinued before Week 12. The overall number of participants analyzed is irrespective of the number of participants providing data or not.
Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.
Outcome measures
| Measure |
LEO 43204 0.018%
n=38 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=38 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Total Lesion Count (Inflammatory and Non-inflammatory)
|
23.57 Lesions
Interval 19.85 to 27.29
|
32.90 Lesions
Interval 29.18 to 36.62
|
SECONDARY outcome
Timeframe: At Week 12 (Day 84)Population: The analysis was based on the full analysis set (FAS). The FAS consisted of all participants except the first 2 participants included in Cohort 1 (according to protocol) were included in the FAS, thus the FAS comprised 38 participants. At Week 12, FAS comprised 32 participants as 6 participants discontinued before Week 12.
Count of inflammatory lesions in acne lesion areas
Outcome measures
| Measure |
LEO 43204 0.018%
n=32 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=32 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Inflammatory Lesion Count
|
3.81 Lesions
Standard Deviation 5.28
|
5.91 Lesions
Standard Deviation 4.55
|
SECONDARY outcome
Timeframe: At Week 12 (Day 84)Population: The analysis was based on the full analysis set (FAS). The FAS consisted of all participants except the first 2 participants included in Cohort 1 (according to protocol) were included in the FAS, thus the FAS comprised 38 participants. At Week 12, FAS comprised 32 participants as 6 participants discontinued before Week 12.
Count of non-inflammatory lesions in acne lesion areas
Outcome measures
| Measure |
LEO 43204 0.018%
n=32 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=32 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Non-inflammatory Lesion Count
|
20.03 Lesions
Standard Deviation 14.25
|
25.31 Lesions
Standard Deviation 19.68
|
SECONDARY outcome
Timeframe: At Week 12 (Day 84)Population: The analysis was based on the full analysis set (FAS). The FAS consisted of all participants except the first 2 participants included in Cohort 1 (according to protocol) were included in the FAS, thus the FAS comprised 38 participants. At Week 12, FAS comprised 32 participants as 6 participants discontinued before Week 12.
The IGA score was determined according to the 5 point scale below. 0=Clear skin with no inflammatory and non-inflammatory lesions 1. Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion 2. Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesions 4. Severe; greater than Grade 3; up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions
Outcome measures
| Measure |
LEO 43204 0.018%
n=32 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=32 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
IGA score 4
|
1 Participants
|
1 Participants
|
|
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
IGA score 1
|
3 Participants
|
2 Participants
|
|
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
IGA score 2
|
19 Participants
|
5 Participants
|
|
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
IGA score 3
|
9 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
The Local Skin Responses consists of the following 6 components: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR component is given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity. The composite LSR score (0-24) is the sum of the scores graded from 0 to 4 on all six individual LSR categories. Please see following outcome measure descriptions on the grading scale for the individual components: * Erosion/ulceration: 6. Secondary outcome measure * Crusting: 7. Secondary outcome measure. * Erythema: 8. Secondary outcome measure. * Flaking/scaling: 9. Secondary outcome measure. * Swelling: 10. Secondary outcome measure. * Vesiculation/pustulation: 11. Secondary outcome measure.
Outcome measures
| Measure |
LEO 43204 0.018%
n=40 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=40 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Composite Local Skin Response (LSR) Score at All Visits
Day 1
|
0.13 score on a scale
Standard Deviation 0.81
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Composite Local Skin Response (LSR) Score at All Visits
Day 2
|
1.34 score on a scale
Standard Deviation 2.18
|
0.41 score on a scale
Standard Deviation 1.50
|
|
Composite Local Skin Response (LSR) Score at All Visits
Day 3
|
3.03 score on a scale
Standard Deviation 2.76
|
0.90 score on a scale
Standard Deviation 2.30
|
|
Composite Local Skin Response (LSR) Score at All Visits
Day 4
|
4.32 score on a scale
Standard Deviation 3.67
|
0.97 score on a scale
Standard Deviation 2.67
|
|
Composite Local Skin Response (LSR) Score at All Visits
Day 8
|
3.00 score on a scale
Standard Deviation 2.62
|
0.19 score on a scale
Standard Deviation 0.54
|
|
Composite Local Skin Response (LSR) Score at All Visits
Week 2
|
1.17 score on a scale
Standard Deviation 1.44
|
0.33 score on a scale
Standard Deviation 1.24
|
|
Composite Local Skin Response (LSR) Score at All Visits
Week 4
|
0.23 score on a scale
Standard Deviation 0.65
|
0.05 score on a scale
Standard Deviation 0.23
|
|
Composite Local Skin Response (LSR) Score at All Visits
Week 8
|
0.12 score on a scale
Standard Deviation 0.69
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Composite Local Skin Response (LSR) Score at All Visits
Week 12
|
0.09 score on a scale
Standard Deviation 0.38
|
0.00 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
The Erosion/Ulceration score was determined according to the 5 point scale below. 0=not present 1. Lesion specific erosion 2. Erosion extending beyond individual lesions 3. Erosion \>50% 4. Black eschar or ulceration
Outcome measures
| Measure |
LEO 43204 0.018%
n=40 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=40 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 1 · Score 0
|
38 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 1 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 1 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 1 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 2 · Score 0
|
38 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 2 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 2 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 2 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 3 · Score 0
|
38 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 3 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 3 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 3 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 4 · Score 0
|
37 Participants
|
38 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 4 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 4 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 4 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 8 · Score 0
|
15 Participants
|
16 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 8 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 8 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Day 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 2 · Score 0
|
35 Participants
|
36 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 2 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 2 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 2 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 4 · Score 0
|
35 Participants
|
37 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 4 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 4 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 4 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 8 · Score 0
|
34 Participants
|
35 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 8 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 8 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 12 · Score 0
|
34 Participants
|
34 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 12 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 12 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erosion/Ulceration
Week 12 · Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
The crusting score was determined according to the 5 point scale below. 0=not present 1. isolated crusting 2. Crusting\<50% 3. Crusting\>50% 4. Crusting extending outside treatment area
Outcome measures
| Measure |
LEO 43204 0.018%
n=40 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=40 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Participant's Component LSR Score: Crusting
Day 1 · Score 0
|
37 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Crusting
Day 1 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Day 1 · Score 2
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Day 1 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Day 2 · Score 0
|
37 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Crusting
Day 2 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Day 2 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Day 2 · Score 3
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Day 3 · Score 0
|
28 Participants
|
36 Participants
|
|
Participant's Component LSR Score: Crusting
Day 3 · Score 1
|
5 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Crusting
Day 3 · Score 2
|
5 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Crusting
Day 3 · Score 3
|
0 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Crusting
Day 4 · Score 0
|
20 Participants
|
33 Participants
|
|
Participant's Component LSR Score: Crusting
Day 4 · Score 1
|
8 Participants
|
2 Participants
|
|
Participant's Component LSR Score: Crusting
Day 4 · Score 2
|
6 Participants
|
2 Participants
|
|
Participant's Component LSR Score: Crusting
Day 4 · Score 3
|
3 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Crusting
Day 8 · Score 0
|
5 Participants
|
15 Participants
|
|
Participant's Component LSR Score: Crusting
Day 8 · Score 1
|
5 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Crusting
Day 8 · Score 2
|
5 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Day 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Week 2 · Score 0
|
24 Participants
|
32 Participants
|
|
Participant's Component LSR Score: Crusting
Week 2 · Score 1
|
8 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Crusting
Week 2 · Score 2
|
3 Participants
|
2 Participants
|
|
Participant's Component LSR Score: Crusting
Week 2 · Score 3
|
0 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Crusting
Week 4 · Score 0
|
33 Participants
|
36 Participants
|
|
Participant's Component LSR Score: Crusting
Week 4 · Score 1
|
2 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Crusting
Week 4 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Week 4 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Week 8 · Score 0
|
33 Participants
|
35 Participants
|
|
Participant's Component LSR Score: Crusting
Week 8 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Week 8 · Score 2
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Week 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Week 12 · Score 0
|
33 Participants
|
34 Participants
|
|
Participant's Component LSR Score: Crusting
Week 12 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Week 12 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Crusting
Week 12 · Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
The erythema score was determined according to the 5 point scale below. Erythema 0=not present 1. slightly pink \<50% 2. Pink or light red \>50% 3. Red,restricted to treatment area 4. Red extending outside treatment area
Outcome measures
| Measure |
LEO 43204 0.018%
n=40 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=40 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Participant's Component LSR Score: Erythema
Day 1 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Day 1 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Day 3 · Score 1
|
11 Participants
|
2 Participants
|
|
Participant's Component LSR Score: Erythema
Day 3 · Score 2
|
13 Participants
|
3 Participants
|
|
Participant's Component LSR Score: Erythema
Day 1 · Score 0
|
38 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Erythema
Day 1 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Day 2 · Score 0
|
20 Participants
|
33 Participants
|
|
Participant's Component LSR Score: Erythema
Day 2 · Score 1
|
8 Participants
|
3 Participants
|
|
Participant's Component LSR Score: Erythema
Day 2 · Score 2
|
6 Participants
|
2 Participants
|
|
Participant's Component LSR Score: Erythema
Day 2 · Score 3
|
4 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Erythema
Day 3 · Score 0
|
9 Participants
|
31 Participants
|
|
Participant's Component LSR Score: Erythema
Day 3 · Score 3
|
5 Participants
|
3 Participants
|
|
Participant's Component LSR Score: Erythema
Day 4 · Score 0
|
10 Participants
|
33 Participants
|
|
Participant's Component LSR Score: Erythema
Day 4 · Score 1
|
8 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Erythema
Day 4 · Score 2
|
9 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Erythema
Day 4 · Score 3
|
10 Participants
|
3 Participants
|
|
Participant's Component LSR Score: Erythema
Day 8 · Score 0
|
9 Participants
|
16 Participants
|
|
Participant's Component LSR Score: Erythema
Day 8 · Score 1
|
4 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Day 8 · Score 2
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Day 8 · Score 3
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 2 · Score 0
|
31 Participants
|
35 Participants
|
|
Participant's Component LSR Score: Erythema
Week 2 · Score 1
|
3 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Erythema
Week 2 · Score 2
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 2 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 4 · Score 0
|
34 Participants
|
37 Participants
|
|
Participant's Component LSR Score: Erythema
Week 4 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 4 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 4 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 8 · Score 0
|
34 Participants
|
35 Participants
|
|
Participant's Component LSR Score: Erythema
Week 8 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 8 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 12 · Score 0
|
34 Participants
|
34 Participants
|
|
Participant's Component LSR Score: Erythema
Week 12 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 12 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Erythema
Week 12 · Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
The flaking/scaling score was determined according to the 5 point scale below. 0=not present 1. Isolated scale, specific to lesion 2. Scale\<50% 3. Scale\>50% 4. Scaling extending outside treatment area
Outcome measures
| Measure |
LEO 43204 0.018%
n=40 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=40 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Participant's Component LSR Score: Flaking/Scaling
Day 4 · Score 3
|
4 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 1 · Score 0
|
37 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 1 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 1 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 1 · Score 3
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 2 · Score 0
|
37 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 2 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 2 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 2 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 3 · Score 0
|
25 Participants
|
36 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 3 · Score 1
|
10 Participants
|
2 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 3 · Score 2
|
3 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 3 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 4 · Score 0
|
15 Participants
|
32 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 4 · Score 1
|
11 Participants
|
3 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 4 · Score 2
|
7 Participants
|
2 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 8 · Score 0
|
3 Participants
|
14 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 8 · Score 1
|
8 Participants
|
2 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 8 · Score 2
|
4 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Day 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 2 · Score 0
|
19 Participants
|
35 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 2 · Score 1
|
11 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 2 · Score 2
|
5 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 2 · Score 3
|
0 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 4 · Score 0
|
30 Participants
|
36 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 4 · Score 1
|
5 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 4 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 4 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 8 · Score 0
|
33 Participants
|
35 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 8 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 8 · Score 2
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 12 · Score 0
|
33 Participants
|
34 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 12 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 12 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Flaking/Scaling
Week 12 · Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
The swelling score was determined according to the 5 point scale below. 0=Not present 1. Slight, lesion specific oedema 2. Palpable oedema extending beyond individual lesions 3. Confluent and/or visible oedema 4. Marked swelling extending outside treatment area
Outcome measures
| Measure |
LEO 43204 0.018%
n=40 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=40 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Participant's Component LSR Score: Swelling
Day 2 · Score 2
|
3 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Swelling
Day 2 · Score 3
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 1 · Score 0
|
38 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Swelling
Day 1 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 1 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 1 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 2 · Score 0
|
32 Participants
|
38 Participants
|
|
Participant's Component LSR Score: Swelling
Day 2 · Score 1
|
2 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 3 · Score 0
|
25 Participants
|
37 Participants
|
|
Participant's Component LSR Score: Swelling
Day 3 · Score 1
|
7 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Swelling
Day 3 · Score 2
|
6 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Swelling
Day 3 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 4 · Score 0
|
27 Participants
|
37 Participants
|
|
Participant's Component LSR Score: Swelling
Day 4 · Score 1
|
8 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Swelling
Day 4 · Score 2
|
2 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 4 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 8 · Score 0
|
14 Participants
|
16 Participants
|
|
Participant's Component LSR Score: Swelling
Day 8 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 8 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Day 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 2 · Score 0
|
35 Participants
|
36 Participants
|
|
Participant's Component LSR Score: Swelling
Week 2 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 2 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 2 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 4 · Score 0
|
35 Participants
|
37 Participants
|
|
Participant's Component LSR Score: Swelling
Week 4 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 4 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 4 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 8 · Score 0
|
34 Participants
|
35 Participants
|
|
Participant's Component LSR Score: Swelling
Week 8 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 8 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 12 · Score 0
|
34 Participants
|
34 Participants
|
|
Participant's Component LSR Score: Swelling
Week 12 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 12 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Swelling
Week 12 · Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
The vesiculation/postulation score was determined according to the 5 point scale below. 0=not present 1. vesicles only 2. Transudate or pustulates with or without vesicles \<50% 3. Transudate or pustulates, with or without vesicles \>50% 4. Transudate or pustulates, with or without vesicles extending outside treatment area 4=Marked swelling extending outside treatment area
Outcome measures
| Measure |
LEO 43204 0.018%
n=40 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=40 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 3 · Score 3
|
1 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 4 · Score 0
|
24 Participants
|
36 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 4 · Score 1
|
4 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 4 · Score 2
|
5 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 4 · Score 3
|
4 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 8 · Score 0
|
13 Participants
|
16 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 8 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 2 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 2 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 3 · Score 2
|
3 Participants
|
1 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 8 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 8 · Score 3
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 2 · Score 0
|
34 Participants
|
36 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 1 · Score 0
|
38 Participants
|
39 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 1 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 1 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 1 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 2 · Score 0
|
36 Participants
|
38 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 2 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 2 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 2 · Score 3
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 3 · Score 0
|
30 Participants
|
37 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Day 3 · Score 1
|
4 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 2 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 4 · Score 0
|
35 Participants
|
37 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 4 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 4 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 4 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 8 · Score 0
|
34 Participants
|
35 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 8 · Score 1
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 8 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 8 · Score 3
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 12 · Score 0
|
33 Participants
|
34 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 12 · Score 1
|
1 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 12 · Score 2
|
0 Participants
|
0 Participants
|
|
Participant's Component LSR Score: Vesiculation/Pustulation
Week 12 · Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12Unacceptable LSRs, safety and tolerability in an individual participant were defined as: 1. Clinically relevant signs or symptoms that in the opinion of the investigator were deemed unacceptable. 2. Occurrence of LSRs as specified below: One of the following * Grade 4 crusting * Grade 4 erosion/ulceration * Grade 4 vesiculation/pustulation extending significantly outside treatment areas Two of the following * Grade 4 erythema * Grade 3 crusting * Grade 4 swelling extending significantly outside treatment areas * Grade 3 erosion/ulceration * Grade 3 vesiculation/pustulation
Outcome measures
| Measure |
LEO 43204 0.018%
n=40 Participants
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
|
Vehicle
n=40 Participants
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
|
|---|---|---|
|
Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits
|
0 Participants
|
0 Participants
|
Adverse Events
Non-cutaneous
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LEO 43204 0.018%
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-cutaneous
n=40 participants at risk
Non-cutaneous adverse events
|
LEO 43204 0.018%
n=40 participants at risk
LEO 43204 0.018% gel administered to an acne lesion on either left or right cheek
|
Vehicle
n=40 participants at risk
LEO 43204 vehicle gel administered to an acne lesion on either left or right cheek
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
0.00%
0/40 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
0.00%
0/40 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
|
General disorders
Application site pruritus
|
0.00%
0/40 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
5.0%
2/40 • Number of events 2 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
0.00%
0/40 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
|
General disorders
Application site pain
|
0.00%
0/40 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
45.0%
18/40 • Number of events 18 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
2.5%
1/40 • Number of events 1 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 1 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
0.00%
0/40 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
0.00%
0/40 • From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
- Publication restrictions are in place
Restriction type: OTHER