Acne Vulgaris
Conditions
Brief summary
An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled, double-blinded, split-pace (left/right) design trial to evaluate the efficacy and tolerability of LEO 43204 in adults with moderate to severe acne.
Interventions
DRUGLEO43204
DRUGPlacebo
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Subjects should be diagnosed with acne vulgaris of the face * Fitzpatrick skin types I-III (due to lack of safety data for the investigational product in darker skin types) * Disease severity and total lesion count should be similar in both TAs * Disease severity grade as moderate to severe according to the investigator's global assessment (grade 3-4) * Age 18 to 35 years incl. * Male or female * Female Subjects must be of either non-childbearing potential or child-bearing potential with a confirmed negative pregnancy test
Exclusion criteria
* Subjects with nodulocystic acne, acne conglobata, acne fulminans, secondary acne (e.g. chlor-acne, drug-induced acne) * Subjects with previous history of keloid formation or post-inflammatory hyperpigmentation * Systemic retinoids within 12 month or systemic antibiotics within 1 month before Day 1 * Topical retinoids within 3 months before Day 1 or other topical treatments and/or medicated products and cosmetics that in the opinion of the investigator may influence the subjects acne vulgaris (including soaps containing antibacterial agents such as benzoyl peroxide, keratinolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) within 1 month before Day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Lesion Count (Inflammatory and Non-inflammatory) | At Week 12 (Day 84) | Total lesion count (inflammatory and non-inflammatory) in acne lesion areas. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-inflammatory Lesion Count | At Week 12 (Day 84) | Count of non-inflammatory lesions in acne lesion areas |
| Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | At Week 12 (Day 84) | 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 |
| Composite Local Skin Response (LSR) Score at All Visits | At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12 | 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. |
| Participant's Component LSR Score: Erosion/Ulceration | At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12 | 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 |
| Participant's Component LSR Score: Crusting | At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12 | 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 |
| Inflammatory Lesion Count | At Week 12 (Day 84) | Count of inflammatory lesions in acne lesion areas |
| Participant's Component LSR Score: Flaking/Scaling | At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12 | 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 |
| Participant's Component LSR Score: Swelling | At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12 | 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 |
| Participant's Component LSR Score: Vesiculation/Pustulation | At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12 | 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 |
| Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits | At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12 | 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 |
| Participant's Component LSR Score: Erythema | At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12 | 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 |
Countries
United States
Participant flow
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.
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 21.9 years STANDARD_DEVIATION 3.8 |
| Age, Customized Years 18-20 | 18 Participants |
| Age, Customized Years 21-24 | 16 Participants |
| Age, Customized Years 25-35 | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 2 / 40 | 18 / 40 | 1 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Total Lesion Count (Inflammatory and Non-inflammatory)
Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| LEO 43204 0.018% | Total Lesion Count (Inflammatory and Non-inflammatory) | 23.57 Lesions |
| Vehicle | Total Lesion Count (Inflammatory and Non-inflammatory) | 32.90 Lesions |
Comparison: 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.p-value: <0.00195% CI: [-14.71, -3.96]ANCOVA
Secondary
Composite Local Skin Response (LSR) Score at All Visits
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
Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Day 1 | 0.13 score on a scale | Standard Deviation 0.81 |
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Week 2 | 1.17 score on a scale | Standard Deviation 1.44 |
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Day 3 | 3.03 score on a scale | Standard Deviation 2.76 |
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Week 4 | 0.23 score on a scale | Standard Deviation 0.65 |
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Day 4 | 4.32 score on a scale | Standard Deviation 3.67 |
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Week 8 | 0.12 score on a scale | Standard Deviation 0.69 |
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Day 2 | 1.34 score on a scale | Standard Deviation 2.18 |
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Week 12 | 0.09 score on a scale | Standard Deviation 0.38 |
| LEO 43204 0.018% | Composite Local Skin Response (LSR) Score at All Visits | Day 8 | 3.00 score on a scale | Standard Deviation 2.62 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Week 12 | 0.00 score on a scale | Standard Deviation 0 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Day 2 | 0.41 score on a scale | Standard Deviation 1.5 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Day 4 | 0.97 score on a scale | Standard Deviation 2.67 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Day 8 | 0.19 score on a scale | Standard Deviation 0.54 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Week 2 | 0.33 score on a scale | Standard Deviation 1.24 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Week 4 | 0.05 score on a scale | Standard Deviation 0.23 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Week 8 | 0.00 score on a scale | Standard Deviation 0 |
| Vehicle | Composite Local Skin Response (LSR) Score at All Visits | Day 3 | 0.90 score on a scale | Standard Deviation 2.3 |
Secondary
Inflammatory Lesion Count
Count of inflammatory lesions in acne lesion areas
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 43204 0.018% | Inflammatory Lesion Count | 3.81 Lesions | Standard Deviation 5.28 |
| Vehicle | Inflammatory Lesion Count | 5.91 Lesions | Standard Deviation 4.55 |
Secondary
Non-inflammatory Lesion Count
Count of non-inflammatory lesions in acne lesion areas
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 43204 0.018% | Non-inflammatory Lesion Count | 20.03 Lesions | Standard Deviation 14.25 |
| Vehicle | Non-inflammatory Lesion Count | 25.31 Lesions | Standard Deviation 19.68 |
Secondary
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
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)
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 43204 0.018% | Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | IGA score 1 | 3 Participants |
| LEO 43204 0.018% | Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | IGA score 2 | 19 Participants |
| LEO 43204 0.018% | Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | IGA score 3 | 9 Participants |
| LEO 43204 0.018% | Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | IGA score 4 | 1 Participants |
| Vehicle | Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | IGA score 4 | 1 Participants |
| Vehicle | Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | IGA score 1 | 2 Participants |
| Vehicle | Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | IGA score 3 | 24 Participants |
| Vehicle | Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area | IGA score 2 | 5 Participants |
Secondary
Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LEO 43204 0.018% | Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits | 0 Participants |
| Vehicle | Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits | 0 Participants |
Secondary
Participant's Component LSR Score: Crusting
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
Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 8 | Score 1 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 3 | Score 1 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 8 | Score 2 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 2 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 3 | Score 2 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 2 | Score 0 | 24 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 1 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 2 | Score 1 | 8 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 3 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 2 | Score 2 | 3 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 2 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 2 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 4 | Score 0 | 20 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 4 | Score 0 | 33 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 1 | Score 2 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 4 | Score 1 | 2 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 8 | Score 2 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 4 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 4 | Score 1 | 8 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 4 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 2 | Score 3 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 8 | Score 0 | 33 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 4 | Score 2 | 6 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 8 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 2 | Score 0 | 37 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 4 | Score 3 | 3 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 12 | Score 0 | 33 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 3 | Score 0 | 28 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 12 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 8 | Score 0 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 12 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 1 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Week 12 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Crusting | Day 1 | Score 0 | 37 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 12 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 1 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 1 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 1 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 1 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 2 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 3 | Score 0 | 36 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 3 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 3 | Score 2 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 3 | Score 3 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 4 | Score 0 | 33 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 4 | Score 1 | 2 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 4 | Score 2 | 2 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 4 | Score 3 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 8 | Score 0 | 15 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 8 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Day 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 2 | Score 0 | 32 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 2 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 2 | Score 2 | 2 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 2 | Score 3 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 4 | Score 0 | 36 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 4 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 4 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 4 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 8 | Score 0 | 35 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 12 | Score 0 | 34 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 12 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Crusting | Week 12 | Score 2 | 0 Participants |
Secondary
Participant's Component LSR Score: Erosion/Ulceration
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
Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 3 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 8 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 2 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 3 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 1 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 2 | Score 0 | 35 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 3 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 2 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 2 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 2 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 4 | Score 0 | 37 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 2 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 1 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 4 | Score 0 | 35 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 4 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 4 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 2 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 4 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 4 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 8 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 2 | Score 0 | 38 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 8 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 4 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 8 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 4 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 3 | Score 0 | 38 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 12 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 8 | Score 0 | 15 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 12 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 1 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 12 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 8 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Week 12 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erosion/Ulceration | Day 1 | Score 0 | 38 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 12 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 1 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 1 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 1 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 1 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 2 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 3 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 3 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 3 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 3 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 4 | Score 0 | 38 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 4 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 4 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 4 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 8 | Score 0 | 16 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Day 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 4 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 2 | Score 0 | 36 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 4 | Score 0 | 37 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 4 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 4 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 8 | Score 0 | 35 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 12 | Score 0 | 34 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 12 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erosion/Ulceration | Week 12 | Score 2 | 0 Participants |
Secondary
Participant's Component LSR Score: Erythema
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
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 8 | Score 2 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 2 | Score 1 | 8 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 8 | Score 3 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 3 | Score 2 | 13 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 2 | Score 0 | 31 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 1 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 2 | Score 1 | 3 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 3 | Score 3 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 2 | Score 2 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 2 | Score 2 | 6 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 2 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 4 | Score 0 | 10 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 4 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 1 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 4 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 4 | Score 1 | 8 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 4 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 2 | Score 3 | 4 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 4 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 4 | Score 2 | 9 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 8 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 2 | Score 0 | 20 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 8 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 4 | Score 3 | 10 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 8 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 3 | Score 0 | 9 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 8 | Score 0 | 9 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 12 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 1 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 12 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 8 | Score 1 | 4 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 12 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 3 | Score 1 | 11 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Week 12 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Erythema | Day 1 | Score 0 | 38 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 12 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 1 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 1 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 1 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 1 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 2 | Score 0 | 33 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 2 | Score 1 | 3 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 2 | Score 2 | 2 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 2 | Score 3 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 3 | Score 0 | 31 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 3 | Score 1 | 2 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 3 | Score 2 | 3 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 3 | Score 3 | 3 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 4 | Score 0 | 33 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 4 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 4 | Score 2 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 4 | Score 3 | 3 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 8 | Score 0 | 16 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Day 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 2 | Score 0 | 35 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 2 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 4 | Score 0 | 37 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 4 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 4 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 4 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 8 | Score 0 | 35 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 12 | Score 0 | 34 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 12 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Erythema | Week 12 | Score 2 | 0 Participants |
Secondary
Participant's Component LSR Score: Flaking/Scaling
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
Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 8 | Score 2 | 4 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 3 | Score 1 | 10 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 2 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 2 | Score 0 | 19 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 3 | Score 2 | 3 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 2 | Score 1 | 11 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 1 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 2 | Score 2 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 3 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 2 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 2 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 4 | Score 0 | 30 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 4 | Score 0 | 15 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 4 | Score 1 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 1 | Score 3 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 4 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 4 | Score 1 | 11 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 4 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 1 | Score 0 | 37 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 8 | Score 0 | 33 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 4 | Score 2 | 7 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 8 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 2 | Score 0 | 37 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 8 | Score 2 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 4 | Score 3 | 4 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 2 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 12 | Score 0 | 33 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 8 | Score 0 | 3 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 12 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 3 | Score 0 | 25 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 12 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 8 | Score 1 | 8 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Week 12 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Flaking/Scaling | Day 1 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 12 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 1 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 1 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 1 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 1 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 3 | Score 0 | 36 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 3 | Score 1 | 2 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 3 | Score 2 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 3 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 4 | Score 0 | 32 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 4 | Score 1 | 3 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 4 | Score 2 | 2 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 4 | Score 3 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 8 | Score 0 | 14 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 8 | Score 1 | 2 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 2 | Score 0 | 35 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 2 | Score 3 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 4 | Score 0 | 36 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 4 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 4 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 4 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 8 | Score 0 | 35 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 12 | Score 0 | 34 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 12 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Week 12 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Flaking/Scaling | Day 2 | Score 0 | 39 Participants |
Secondary
Participant's Component LSR Score: Swelling
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
Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 8 | Score 0 | 14 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 1 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 8 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 3 | Score 0 | 25 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 8 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 1 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 3 | Score 1 | 7 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 2 | Score 0 | 35 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 2 | Score 0 | 32 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 2 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 3 | Score 2 | 6 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 2 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 1 | Score 0 | 38 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 2 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 3 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 4 | Score 0 | 35 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 2 | Score 1 | 2 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 4 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 4 | Score 0 | 27 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 4 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 1 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 4 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 4 | Score 1 | 8 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 8 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 8 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 2 | Score 2 | 3 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 4 | Score 2 | 2 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 12 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 8 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 12 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 4 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 12 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Day 2 | Score 3 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Swelling | Week 12 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 12 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 1 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 1 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 1 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 1 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 2 | Score 0 | 38 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 2 | Score 2 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 3 | Score 0 | 37 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 3 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 3 | Score 2 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 3 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 4 | Score 0 | 37 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 4 | Score 1 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 4 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 4 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 8 | Score 0 | 16 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Day 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 2 | Score 0 | 36 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 4 | Score 0 | 37 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 4 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 4 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 4 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 8 | Score 0 | 35 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 12 | Score 0 | 34 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 12 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Swelling | Week 12 | Score 2 | 0 Participants |
Secondary
Participant's Component LSR Score: Vesiculation/Pustulation
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
Population: 6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 8 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 2 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 8 | Score 3 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 3 | Score 2 | 3 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 2 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 1 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 2 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 3 | Score 3 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 2 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 2 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 2 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 4 | Score 0 | 24 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 4 | Score 0 | 35 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 1 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 4 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 4 | Score 1 | 4 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 4 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 2 | Score 3 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 4 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 4 | Score 2 | 5 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 8 | Score 0 | 34 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 2 | Score 0 | 36 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 8 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 4 | Score 3 | 4 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 8 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 3 | Score 0 | 30 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 8 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 8 | Score 0 | 13 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 12 | Score 0 | 33 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 1 | Score 1 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 12 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 8 | Score 1 | 1 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 12 | Score 2 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 3 | Score 1 | 4 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Week 12 | Score 3 | 0 Participants |
| LEO 43204 0.018% | Participant's Component LSR Score: Vesiculation/Pustulation | Day 1 | Score 0 | 38 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 12 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 1 | Score 0 | 39 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 1 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 1 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 1 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 2 | Score 0 | 38 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 3 | Score 0 | 37 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 3 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 3 | Score 2 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 3 | Score 3 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 4 | Score 0 | 36 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 4 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 4 | Score 2 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 4 | Score 3 | 1 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 8 | Score 0 | 16 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Day 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 2 | Score 0 | 36 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 2 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 2 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 2 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 4 | Score 0 | 37 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 4 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 4 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 4 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 8 | Score 0 | 35 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 8 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 8 | Score 2 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 8 | Score 3 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 12 | Score 0 | 34 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 12 | Score 1 | 0 Participants |
| Vehicle | Participant's Component LSR Score: Vesiculation/Pustulation | Week 12 | Score 2 | 0 Participants |