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Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02575950
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: LEO43204
Drug: Placebo
Enrollment 59
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 3 6 6 25
Completed 3 5 6 20
Not Completed 0 1 0 5
Reason Not Completed
Withdrawal by Subject             0             0             0             2
Lost to Follow-up             0             1             0             3
Arm/Group Title Total
Hide Arm/Group Description All participants randomized to treatment
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
21.9  (3.8)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Years Number Analyzed 40 participants
18-20
18
  45.0%
21-24
16
  40.0%
25-35
6
  15.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
16
  40.0%
Male
24
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
27
  67.5%
Not Hispanic or Latino
13
  32.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
 100.0%
1.Primary Outcome
Title Total Lesion Count (Inflammatory and Non-inflammatory)
Hide Description Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.
Time Frame At Week 12 (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 38 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Lesions
23.57
(19.85 to 27.29)
32.90
(29.18 to 36.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 43204 0.018%, Vehicle
Comments Least square mean values and difference is from ANCOVA model with treatment as fixed effect and baseline total lesion count as covariate and participants as random effect. 100 simulations of monotone multiple imputation is performed. Summary statistics are found across these 100 simulations.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.34
Confidence Interval (2-Sided) 95%
-14.71 to -3.96
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Inflammatory Lesion Count
Hide Description Count of inflammatory lesions in acne lesion areas
Time Frame At Week 12 (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: Lesions
3.81  (5.28) 5.91  (4.55)
3.Secondary Outcome
Title Non-inflammatory Lesion Count
Hide Description Count of non-inflammatory lesions in acne lesion areas
Time Frame At Week 12 (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: Lesions
20.03  (14.25) 25.31  (19.68)
4.Secondary Outcome
Title Number of Participants Stratified by Investigator’s Global Assessment (IGA) of the Treatment Area
Hide Description

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
Time Frame At Week 12 (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
IGA score 1
3
   9.4%
2
   6.3%
IGA score 2
19
  59.4%
5
  15.6%
IGA score 3
9
  28.1%
24
  75.0%
IGA score 4
1
   3.1%
1
   3.1%
5.Secondary Outcome
Title Composite Local Skin Response (LSR) Score at All Visits
Hide Description

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.
Time Frame At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 1 Number Analyzed 38 participants 39 participants
0.13  (0.81) 0.00  (0.00)
Day 2 Number Analyzed 38 participants 39 participants
1.34  (2.18) 0.41  (1.50)
Day 3 Number Analyzed 38 participants 39 participants
3.03  (2.76) 0.90  (2.30)
Day 4 Number Analyzed 37 participants 38 participants
4.32  (3.67) 0.97  (2.67)
Day 8 Number Analyzed 15 participants 16 participants
3.00  (2.62) 0.19  (0.54)
Week 2 Number Analyzed 35 participants 36 participants
1.17  (1.44) 0.33  (1.24)
Week 4 Number Analyzed 35 participants 37 participants
0.23  (0.65) 0.05  (0.23)
Week 8 Number Analyzed 34 participants 35 participants
0.12  (0.69) 0.00  (0.00)
Week 12 Number Analyzed 34 participants 34 participants
0.09  (0.38) 0.00  (0.00)
6.Secondary Outcome
Title Participant's Component LSR Score: Erosion/Ulceration
Hide Description

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
Time Frame At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 38 participants 39 participants
Score 0
38
 100.0%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 2 Number Analyzed 38 participants 39 participants
Score 0
38
 100.0%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 3 Number Analyzed 38 participants 39 participants
Score 0
38
 100.0%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 4 Number Analyzed 37 participants 38 participants
Score 0
37
 100.0%
38
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 8 Number Analyzed 15 participants 16 participants
Score 0
15
 100.0%
16
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 2 Number Analyzed 35 participants 36 participants
Score 0
35
 100.0%
36
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 4 Number Analyzed 35 participants 37 participants
Score 0
35
 100.0%
37
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 34 participants 35 participants
Score 0
34
 100.0%
35
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 12 Number Analyzed 34 participants 34 participants
Score 0
34
 100.0%
34
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Participant's Component LSR Score: Crusting
Hide Description

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
Time Frame At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 38 participants 39 participants
Score 0
37
  97.4%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
1
   2.6%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 2 Number Analyzed 38 participants 39 participants
Score 0
37
  97.4%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
1
   2.6%
0
   0.0%
Day 3 Number Analyzed 38 participants 39 participants
Score 0
28
  73.7%
36
  92.3%
Score 1
5
  13.2%
1
   2.6%
Score 2
5
  13.2%
1
   2.6%
Score 3
0
   0.0%
1
   2.6%
Day 4 Number Analyzed 37 participants 38 participants
Score 0
20
  54.1%
33
  86.8%
Score 1
8
  21.6%
2
   5.3%
Score 2
6
  16.2%
2
   5.3%
Score 3
3
   8.1%
1
   2.6%
Day 8 Number Analyzed 15 participants 16 participants
Score 0
5
  33.3%
15
  93.8%
Score 1
5
  33.3%
1
   6.3%
Score 2
5
  33.3%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 2 Number Analyzed 35 participants 36 participants
Score 0
24
  68.6%
32
  88.9%
Score 1
8
  22.9%
1
   2.8%
Score 2
3
   8.6%
2
   5.6%
Score 3
0
   0.0%
1
   2.8%
Week 4 Number Analyzed 35 participants 37 participants
Score 0
33
  94.3%
36
  97.3%
Score 1
2
   5.7%
1
   2.7%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 34 participants 35 participants
Score 0
33
  97.1%
35
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
1
   2.9%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 12 Number Analyzed 34 participants 34 participants
Score 0
33
  97.1%
34
 100.0%
Score 1
1
   2.9%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Participant's Component LSR Score: Erythema
Time Frame At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 38 participants 39 participants
Score 0
38
 100.0%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 2 Number Analyzed 38 participants 39 participants
Score 0
20
  52.6%
33
  84.6%
Score 1
8
  21.1%
3
   7.7%
Score 2
6
  15.8%
2
   5.1%
Score 3
4
  10.5%
1
   2.6%
Day 3 Number Analyzed 38 participants 39 participants
Score 0
9
  23.7%
31
  79.5%
Score 1
11
  28.9%
2
   5.1%
Score 2
13
  34.2%
3
   7.7%
Score 3
5
  13.2%
3
   7.7%
Day 4 Number Analyzed 37 participants 38 participants
Score 0
10
  27.0%
33
  86.8%
Score 1
8
  21.6%
1
   2.6%
Score 2
9
  24.3%
1
   2.6%
Score 3
10
  27.0%
3
   7.9%
Day 8 Number Analyzed 15 participants 16 participants
Score 0
9
  60.0%
16
 100.0%
Score 1
4
  26.7%
0
   0.0%
Score 2
1
   6.7%
0
   0.0%
Score 3
1
   6.7%
0
   0.0%
Week 2 Number Analyzed 35 participants 36 participants
Score 0
31
  88.6%
35
  97.2%
Score 1
3
   8.6%
1
   2.8%
Score 2
1
   2.9%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 4 Number Analyzed 35 participants 37 participants
Score 0
34
  97.1%
37
 100.0%
Score 1
1
   2.9%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 34 participants 35 participants
Score 0
34
 100.0%
35
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 12 Number Analyzed 34 participants 34 participants
Score 0
34
 100.0%
34
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Participant's Component LSR Score: Flaking/Scaling
Hide Description

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
Time Frame At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 38 participants 39 participants
Score 0
37
  97.4%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
1
   2.6%
0
   0.0%
Day 2 Number Analyzed 38 participants 39 participants
Score 0
37
  97.4%
39
 100.0%
Score 1
1
   2.6%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 3 Number Analyzed 38 participants 39 participants
Score 0
25
  65.8%
36
  92.3%
Score 1
10
  26.3%
2
   5.1%
Score 2
3
   7.9%
1
   2.6%
Score 3
0
   0.0%
0
   0.0%
Day 4 Number Analyzed 37 participants 38 participants
Score 0
15
  40.5%
32
  84.2%
Score 1
11
  29.7%
3
   7.9%
Score 2
7
  18.9%
2
   5.3%
Score 3
4
  10.8%
1
   2.6%
Day 8 Number Analyzed 15 participants 16 participants
Score 0
3
  20.0%
14
  87.5%
Score 1
8
  53.3%
2
  12.5%
Score 2
4
  26.7%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 2 Number Analyzed 35 participants 36 participants
Score 0
19
  54.3%
35
  97.2%
Score 1
11
  31.4%
0
   0.0%
Score 2
5
  14.3%
0
   0.0%
Score 3
0
   0.0%
1
   2.8%
Week 4 Number Analyzed 35 participants 37 participants
Score 0
30
  85.7%
36
  97.3%
Score 1
5
  14.3%
1
   2.7%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 34 participants 35 participants
Score 0
33
  97.1%
35
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
1
   2.9%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 12 Number Analyzed 34 participants 34 participants
Score 0
33
  97.1%
34
 100.0%
Score 1
1
   2.9%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Participant's Component LSR Score: Swelling
Hide Description

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
Time Frame At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 38 participants 39 participants
Score 0
38
 100.0%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 2 Number Analyzed 38 participants 39 participants
Score 0
32
  84.2%
38
  97.4%
Score 1
2
   5.3%
0
   0.0%
Score 2
3
   7.9%
1
   2.6%
Score 3
1
   2.6%
0
   0.0%
Day 3 Number Analyzed 38 participants 39 participants
Score 0
25
  65.8%
37
  94.9%
Score 1
7
  18.4%
1
   2.6%
Score 2
6
  15.8%
1
   2.6%
Score 3
0
   0.0%
0
   0.0%
Day 4 Number Analyzed 37 participants 38 participants
Score 0
27
  73.0%
37
  97.4%
Score 1
8
  21.6%
1
   2.6%
Score 2
2
   5.4%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 8 Number Analyzed 15 participants 16 participants
Score 0
14
  93.3%
16
 100.0%
Score 1
1
   6.7%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 2 Number Analyzed 35 participants 36 participants
Score 0
35
 100.0%
36
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 4 Number Analyzed 35 participants 37 participants
Score 0
35
 100.0%
37
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 34 participants 35 participants
Score 0
34
 100.0%
35
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 12 Number Analyzed 34 participants 34 participants
Score 0
34
 100.0%
34
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Participant's Component LSR Score: Vesiculation/Pustulation
Hide Description

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

Time Frame At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 38 participants 39 participants
Score 0
38
 100.0%
39
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Day 2 Number Analyzed 38 participants 38 participants
Score 0
36
  94.7%
38
 100.0%
Score 1
1
   2.6%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
1
   2.6%
0
   0.0%
Day 3 Number Analyzed 38 participants 39 participants
Score 0
30
  78.9%
37
  94.9%
Score 1
4
  10.5%
0
   0.0%
Score 2
3
   7.9%
1
   2.6%
Score 3
1
   2.6%
1
   2.6%
Day 4 Number Analyzed 37 participants 38 participants
Score 0
24
  64.9%
36
  94.7%
Score 1
4
  10.8%
0
   0.0%
Score 2
5
  13.5%
1
   2.6%
Score 3
4
  10.8%
1
   2.6%
Day 8 Number Analyzed 15 participants 16 participants
Score 0
13
  86.7%
16
 100.0%
Score 1
1
   6.7%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
1
   6.7%
0
   0.0%
Week 2 Number Analyzed 35 participants 36 participants
Score 0
34
  97.1%
36
 100.0%
Score 1
1
   2.9%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 4 Number Analyzed 35 participants 37 participants
Score 0
35
 100.0%
37
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 34 participants 35 participants
Score 0
34
 100.0%
35
 100.0%
Score 1
0
   0.0%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
Week 12 Number Analyzed 34 participants 34 participants
Score 0
33
  97.1%
34
 100.0%
Score 1
1
   2.9%
0
   0.0%
Score 2
0
   0.0%
0
   0.0%
Score 3
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits
Hide Description

Unacceptable 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
Time Frame At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 43204 0.018% Vehicle
Hide Arm/Group Description:
LEO 43204 0.018% gel administered in acne lesion area on either left or right cheek
LEO 43204 vehicle gel administered in acne lesion area on either left or right cheek
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame From baseline (Day 1) to post treatment follow-up (end of treatment to Week 12)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-cutaneous LEO 43204 0.018% Vehicle
Hide Arm/Group Description Non-cutaneous adverse events LEO 43204 0.018% gel administered to an acne lesion on either left or right cheek LEO 43204 vehicle gel administered to an acne lesion on either left or right cheek
All-Cause Mortality
Non-cutaneous LEO 43204 0.018% Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/40 (0.00%)      0/40 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Non-cutaneous LEO 43204 0.018% Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-cutaneous LEO 43204 0.018% Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/40 (5.00%)      18/40 (45.00%)      1/40 (2.50%)    
Gastrointestinal disorders       
Nausea * 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
General disorders       
Application site pruritus * 1  0/40 (0.00%)  0 2/40 (5.00%)  2 0/40 (0.00%)  0
Application site pain * 1  0/40 (0.00%)  0 18/40 (45.00%)  18 1/40 (2.50%)  1
Nervous system disorders       
Headache * 1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: LEO Pharma A/S
Phone: +45 4494 5888
EMail: disclosure@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02575950     History of Changes
Other Study ID Numbers: EXP-1223
First Submitted: October 13, 2015
First Posted: October 15, 2015
Results First Submitted: December 27, 2018
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019