Trial Outcomes & Findings for Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up (NCT NCT02547233)

Last Updated: 2025-03-10

Results Overview

Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs (actinic keratosis lesions) in the treatment area. The table shows the percentage of mean number of subjects across imputations with complete clearance.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

437 participants

Primary outcome timeframe

At Week 8

Results posted on

2025-03-10

Participant Flow

A total of 437 participants were enrolled across 4 countries: United States, United Kingdom, France, and Spain. 130 were screening failures, and 307 participants were randomized to 1 of the 2 treatment groups

Participant milestones

Participant milestones
Measure	LEO 43204 0.018% Gel Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.	Vehicle Gel Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
3-day Treatment and 8-week Follow-up STARTED	205	102
3-day Treatment and 8-week Follow-up Treated	205	100
3-day Treatment and 8-week Follow-up COMPLETED	203	92
3-day Treatment and 8-week Follow-up NOT COMPLETED	2	10
12-month Follow-up STARTED	199	84
12-month Follow-up COMPLETED	185	67
12-month Follow-up NOT COMPLETED	14	17

Reasons for withdrawal

Reasons for withdrawal
Measure	LEO 43204 0.018% Gel Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.	Vehicle Gel Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.
3-day Treatment and 8-week Follow-up Adverse Event	1	0
3-day Treatment and 8-week Follow-up Unacceptable Local Skin Response	1	0
3-day Treatment and 8-week Follow-up Withdrawal by Subject	0	9
3-day Treatment and 8-week Follow-up Lost to Follow-up	0	1
12-month Follow-up Withdrawal by Subject	10	10
12-month Follow-up Lost to Follow-up	3	3
12-month Follow-up Lack of Efficacy	1	2
12-month Follow-up Protocol Violation	0	1
12-month Follow-up Other	0	1

Baseline Characteristics

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 43204 0.018% Gel n=205 Participants Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel n=100 Participants Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel	Total n=305 Participants Total of all reporting groups
Age, Continuous	68.2 years STANDARD_DEVIATION 8.9 • n=5 Participants	67.4 years STANDARD_DEVIATION 9.9 • n=7 Participants	67.9 years STANDARD_DEVIATION 9.2 • n=5 Participants
Age, Customized Age group · 18-64 years	73 Participants n=5 Participants	34 Participants n=7 Participants	107 Participants n=5 Participants
Age, Customized Age group · 65-84 years	129 Participants n=5 Participants	64 Participants n=7 Participants	193 Participants n=5 Participants
Age, Customized Age group · >=85 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	38 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants	62 Participants n=7 Participants	200 Participants n=5 Participants
Region of Enrollment United States	165 Participants n=5 Participants	79 Participants n=7 Participants	244 Participants n=5 Participants
Region of Enrollment France	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United Kingdom	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Spain	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 8

Outcome measures

Outcome measures
Measure	LEO 43204 0.018% Gel n=205 Participants Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel n=100 Participants Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)	31.3 percentage of participants Interval 24.9 to 37.6	1.0 percentage of participants Interval -1.0 to 3.1

SECONDARY outcome

Timeframe: At Week 8

Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with partial clearance.

Outcome measures

Outcome measures
Measure	LEO 43204 0.018% Gel n=205 Participants Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel n=100 Participants Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
Percentage of Participants With Partial Clearance (Multiple Imputation)	55.8 percentage of participants Interval 49.0 to 62.7	4.6 percentage of participants Interval 0.3 to 8.9

SECONDARY outcome

Timeframe: At Week 4

Outcome measures

Outcome measures
Measure	LEO 43204 0.018% Gel n=205 Participants Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel n=100 Participants Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
Percentage of Participants With Partial Clearance (Multiple Imputation)	56.6 percentage of participants Interval 49.7 to 63.4	5.5 percentage of participants Interval 0.9 to 10.2

SECONDARY outcome

Timeframe: At Week 8

The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.

Outcome measures

Outcome measures
Measure	LEO 43204 0.018% Gel n=205 Participants Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel n=100 Participants Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
Percent Reduction in AK Count in the Treatment Area Compared to Baseline	72.1 percentage of reduction Interval 68.3 to 75.5	7.3 percentage of reduction Interval -7.8 to 20.3

Adverse Events

LEO 43204 0.018% Gel - Treatment Period Including Follow-up

Serious events: 2 serious events

Other events: 134 other events

Deaths: 0 deaths

Vehicle Gel - Treatment Period Including Follow-up

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LEO 43204 0.018% Gel - Extended Follow-up

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Vehicle Gel - Extended Follow-up

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LEO 43204 0.018% Gel - Treatment Period Including Follow-up n=205 participants at risk Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel - Treatment Period Including Follow-up n=100 participants at risk Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel	LEO 43204 0.018% Gel - Extended Follow-up n=199 participants at risk Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel - Extended Follow-up n=84 participants at risk Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
Blood and lymphatic system disorders Pancytopenia	0.49% 1/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
General disorders Pyrexia	0.49% 1/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Hepatobiliary disorders Jaundice	0.49% 1/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Injury, poisoning and procedural complications Rib fracture	0.49% 1/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Investigations Liver function test abnormal	0.49% 1/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Metabolism and nutrition disorders Dehydration	0.49% 1/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Metabolism and nutrition disorders Hyponatraemia	0.49% 1/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.

Other adverse events

Other adverse events
Measure	LEO 43204 0.018% Gel - Treatment Period Including Follow-up n=205 participants at risk Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel - Treatment Period Including Follow-up n=100 participants at risk Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel	LEO 43204 0.018% Gel - Extended Follow-up n=199 participants at risk Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel	Vehicle Gel - Extended Follow-up n=84 participants at risk Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel
Eye disorders Periorbital oedema	3.9% 8/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
General disorders Application site discomfort	2.9% 6/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
General disorders Application site pain	58.5% 120/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	1.0% 1/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
General disorders Application site paraesthesia	2.4% 5/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
General disorders Application site pruritus	34.6% 71/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Injury, poisoning and procedural complications Scar	0.00% 0/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	4.5% 9/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	1.2% 1/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.0% 4/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	1.0% 1/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	4.5% 9/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	1.2% 1/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	3.9% 8/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	2.0% 2/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	5.0% 10/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	1.2% 1/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Nervous system disorders Headache	4.9% 10/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Psychiatric disorders Insomnia	5.4% 11/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Psychiatric disorders Sleep disorder	2.9% 6/205 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/199 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.	0.00% 0/84 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14) Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.

Additional Information

Clinical Trial Disclosure Specialist

LEO Pharma A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Publication restrictions are in place

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