Trial Outcomes & Findings for Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up (NCT NCT02547363)

Last Updated: 2025-03-10

Results Overview

The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8. Complete clearance was defined as no clinically visible AKs in the treatment area.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

373 participants

Primary outcome timeframe

At Week 8

Results posted on

2025-03-10

Participant Flow

373 participants were enrolled, 57 were screening failures, and 316 participants were randomized. Only 313 of the randomized participants were treated with investigational medicinal product (IMP), the number of participants treated is reflected as the number of participants started in the first period.

Participant milestones

Participant milestones
Measure	LEO 43204 0.037% Gel Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.	Vehicle Gel Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
3-day Treatment and 8-week Follow-up STARTED	211	105
3-day Treatment and 8-week Follow-up Treated	209	104
3-day Treatment and 8-week Follow-up COMPLETED	207	94
3-day Treatment and 8-week Follow-up NOT COMPLETED	4	11
12-month Follow-up STARTED	204	86
12-month Follow-up COMPLETED	194	81
12-month Follow-up NOT COMPLETED	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	LEO 43204 0.037% Gel Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.	Vehicle Gel Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
3-day Treatment and 8-week Follow-up Adverse Event	0	1
3-day Treatment and 8-week Follow-up Withdrawal by Subject	2	8
3-day Treatment and 8-week Follow-up Lost to Follow-up	1	1
3-day Treatment and 8-week Follow-up Other	1	1
12-month Follow-up Withdrawal by Subject	4	3
12-month Follow-up Lost to Follow-up	4	1
12-month Follow-up Lack of Efficacy	1	1
12-month Follow-up Other	1	0

Baseline Characteristics

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 43204 0.037% Gel n=209 Participants Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel	Total n=313 Participants Total of all reporting groups
Age, Continuous	70.9 years STANDARD_DEVIATION 9.1 • n=5 Participants	69.9 years STANDARD_DEVIATION 9.3 • n=7 Participants	70.5 years STANDARD_DEVIATION 9.2 • n=5 Participants
Age, Customized Age group · 18-64 years	45 Participants n=5 Participants	28 Participants n=7 Participants	73 Participants n=5 Participants
Age, Customized Age group · 65-84 years	155 Participants n=5 Participants	70 Participants n=7 Participants	225 Participants n=5 Participants
Age, Customized Age group · >=85 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	208 Participants n=5 Participants	104 Participants n=7 Participants	312 Participants n=5 Participants
Region of Enrollment Canada	69 Participants n=5 Participants	37 Participants n=7 Participants	106 Participants n=5 Participants
Region of Enrollment France	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United Kingdom	18 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	109 Participants n=5 Participants	51 Participants n=7 Participants	160 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 8

Outcome measures

Outcome measures
Measure	LEO 43204 0.037% Gel n=209 Participants Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)	25.8 percentage of participants Interval 20.4 to 32.2	0.0 percentage of participants Interval 0.0 to 3.6

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.

Outcome measures

Outcome measures
Measure	LEO 43204 0.037% Gel n=209 Participants Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel
Percentage of Participants With Partial Clearance of AKs	58.9 percentage of participants Interval 52.1 to 65.3	1.0 percentage of participants Interval 0.2 to 5.2

SECONDARY outcome

Timeframe: At Week 4

Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

Outcome measures

Outcome measures
Measure	LEO 43204 0.037% Gel n=209 Participants Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel
Percentage of Participants With Partial Clearance of AKs	57.4 percentage of participants Interval 50.6 to 63.9	1.0 percentage of participants Interval 0.2 to 5.2

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. The table presents adjusted mean percent reduction at Week 8 from baseline.

Outcome measures

Outcome measures
Measure	LEO 43204 0.037% Gel n=209 Participants Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel n=104 Participants Treatment once daily for 3 days with vehicle gel
Percent Reduction in AK Count in the Treatment Area Compared to Baseline	72.3 percentage of reduction Interval 69.1 to 75.2	-2.0 percentage of reduction Interval -16.0 to 10.3

Adverse Events

LEO 43204 0.037% Gel

Serious events: 4 serious events

Other events: 153 other events

Deaths: 0 deaths

Vehicle Gel

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

LEO 43204 0.037% Gel - Extended Follow-up

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Vehicle Gel - Extended Follow-up

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LEO 43204 0.037% Gel n=209 participants at risk Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel n=104 participants at risk Treatment once daily for 3 days with vehicle gel	LEO 43204 0.037% Gel - Extended Follow-up n=204 participants at risk Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel - Extended Follow-up n=86 participants at risk Treatment once daily for 3 days with vehicle gel
Cardiac disorders Acute myocardial infarction	0.48% 1/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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.
Cardiac disorders Pericarditis	0.48% 1/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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.
Cardiac disorders Sinus node dysfunction	0.00% 0/209 • 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.	0.96% 1/104 • 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% 0/204 • 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% 0/86 • 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.
Infections and infestations Appendicitis perforated	0.48% 1/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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) Neoplasm of appendix	0.48% 1/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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) Pancreatic carcinoma	0.00% 0/209 • 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.	0.96% 1/104 • 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% 0/204 • 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% 0/86 • 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 Mental status changes	0.48% 1/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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) Malignant melanoma	0.00% 0/209 • 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% 0/104 • 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.	0.49% 1/204 • 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% 0/86 • 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 0.037% Gel n=209 participants at risk Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel n=104 participants at risk Treatment once daily for 3 days with vehicle gel	LEO 43204 0.037% Gel - Extended Follow-up n=204 participants at risk Treatment once daily for 3 days with LEO 43204 0.037% gel	Vehicle Gel - Extended Follow-up n=86 participants at risk Treatment once daily for 3 days with vehicle gel
Eye disorders Periorbital oedema	6.7% 14/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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% 6/209 • 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.	1.9% 2/104 • 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% 0/204 • 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% 0/86 • 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 injury	3.8% 8/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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	60.8% 127/209 • 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.	2.9% 3/104 • 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% 0/204 • 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% 0/86 • 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	30.6% 64/209 • 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.	1.9% 2/104 • 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% 0/204 • 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% 0/86 • 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 scar	0.48% 1/209 • 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.	0.96% 1/104 • 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.	4.9% 10/204 • 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.	8.1% 7/86 • 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 Face oedema	2.4% 5/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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.
Infections and infestations Nasopharyngitis	2.9% 6/209 • 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.	0.96% 1/104 • 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% 0/204 • 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% 0/86 • 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	0.00% 0/209 • 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% 0/104 • 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.	2.5% 5/204 • 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% 1/86 • 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	10.0% 21/209 • 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.	1.9% 2/104 • 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% 0/204 • 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% 0/86 • 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	2.4% 5/209 • 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% 0/104 • 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% 0/204 • 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% 0/86 • 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.
Skin and subcutaneous tissue disorders Post inflammatory pigmentation change	0.00% 0/209 • 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% 0/104 • 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.	2.5% 5/204 • 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.	5.8% 5/86 • 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

Restriction type: OTHER