Trial Outcomes & Findings for Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5% (NCT NCT01926496)

NCT ID: NCT01926496

Last Updated: 2025-03-07

Results Overview

Cumulative incidence of SCC after treatment with ingenol mebutate gel and imiquimod cream.\> The primary response criterion is diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period.\> Kaplan-Meier estimate based on time to SCC or censoring.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

485 participants

Primary outcome timeframe

3 years

Results posted on

2025-03-07

Participant Flow

The clinical trial was performed at 44 sites in 3 countries: France, 11 sites; Germany, 15 sites; and United Kingdom, 18 sites

Participant milestones

Participant milestones
Measure	Ingenol Mebutate Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8\> \> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.	Imiquimod Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected\> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8\> \> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Overall Study STARTED	240	245
Overall Study COMPLETED	203	197
Overall Study NOT COMPLETED	37	48

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ingenol Mebutate n=240 Participants Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8\> \> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.	Imiquimod n=244 Participants Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected\> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8\> \> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs	Total n=484 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	42 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical >=65 years	206 Participants n=5 Participants	202 Participants n=7 Participants	408 Participants n=5 Participants
Age, Continuous	72.5 years STANDARD_DEVIATION 7.1 • n=5 Participants	72.0 years STANDARD_DEVIATION 8.0 • n=7 Participants	72.3 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	230 Participants n=5 Participants	229 Participants n=7 Participants	459 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	226 Participants n=5 Participants	232 Participants n=7 Participants	458 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	240 Participants n=5 Participants	244 Participants n=7 Participants	484 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	80 Participants n=5 Participants	81 Participants n=7 Participants	161 Participants n=5 Participants
Region of Enrollment France	60 Participants n=5 Participants	63 Participants n=7 Participants	123 Participants n=5 Participants
Region of Enrollment Germany	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Safety analysis set: all treated subjects

Outcome measures

Outcome measures
Measure	Ingenol Mebutate n=240 Participants Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8\> \> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.	Imiquimod n=244 Participants Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected\> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8\> \> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Incidence of SCC	3.1 percentage of subjects Interval 1.4 to 6.0	0.4 percentage of subjects Interval 0.0 to 2.2

SECONDARY outcome

Timeframe: 3 years

Population: Safety analysis set: all treated subjects

Cumulative incidence of SCC and other neoplasia after treatment with ingenol mebutate gel and imiquimod cream.\> The secondary response criterion is diagnosis of SCC and other neoplasia in the treatment field across the 3-year trial period.\> Kaplan-Meier estimate based on time to SCC and other neoplasia, or censoring.

Outcome measures

Outcome measures
Measure	Ingenol Mebutate n=240 Participants Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8\> \> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.	Imiquimod n=244 Participants Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected\> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8\> \> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Incidence of SCC and Other Neoplasia	6.2 percentage of subjects Interval 3.5 to 9.8	2.3 percentage of subjects Interval 0.9 to 4.9

SECONDARY outcome

Timeframe: 8-16 weeks

Population: Full analysis set: all randomised subjects

To compare the complete clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16)

Outcome measures

Outcome measures
Measure	Ingenol Mebutate n=240 Participants Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8\> \> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.	Imiquimod n=245 Participants Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected\> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8\> \> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Number of Participants With Complete Clearance of AK Lesions After Last Treatment	168 Participants	192 Participants

SECONDARY outcome

Timeframe: 8-16 weeks

Population: Full analysis set: all randomised subjects

To compare the partial (at least 75%) clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16)

Outcome measures

Outcome measures
Measure	Ingenol Mebutate n=240 Participants Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8\> \> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.	Imiquimod n=245 Participants Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected\> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8\> \> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Number of Participants With Partial Clearance of AK Lesions	195 Participants	210 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Full analysis set: all randomised subjects.

To compare the complete clearance of AK lesions at 12 months, defined as no AK lesions in the selected treatment area at any time from the last treatment cycle at Week 8 or 16 through to Month 12.

Outcome measures

Outcome measures
Measure	Ingenol Mebutate n=240 Participants Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8\> \> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.	Imiquimod n=245 Participants Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected\> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8\> \> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Number of Participants With Complete Clearance of AK Lesions at 12 Months	70 Participants	108 Participants

Adverse Events

Ingenol Mebutate Until Week 20

Serious events: 21 serious events

Other events: 67 other events

Deaths: 0 deaths

Imiquimod Until Week 20

Serious events: 14 serious events

Other events: 70 other events

Deaths: 1 deaths

Ingenol Mebutate After Week 20

Serious events: 11 serious events

Other events: 51 other events

Deaths: 8 deaths

Imiquimod After Week 20

Serious events: 2 serious events

Other events: 50 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ingenol Mebutate Until Week 20 n=240 participants at risk Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8. Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.	Imiquimod Until Week 20 n=244 participants at risk Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8 Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs	Ingenol Mebutate After Week 20 n=240 participants at risk Ingenol mebutate Week 20 is the first week of the follow-up period.	Imiquimod After Week 20 n=244 participants at risk Imiquimod Week 20 is the first week of the follow-up period.
Eye disorders Eye swelling	2.5% 6/240 • Number of events 6 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Eye disorders Eyelid oedema	3.3% 8/240 • Number of events 9 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Gastrointestinal disorders Nausea	1.2% 3/240 • Number of events 3 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	2.0% 5/244 • Number of events 5 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
General disorders Application site pain	9.2% 22/240 • Number of events 28 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	6.1% 15/244 • Number of events 17 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.42% 1/240 • Number of events 2 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
General disorders Application site pruritus	5.8% 14/240 • Number of events 15 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	5.3% 13/244 • Number of events 15 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
General disorders Fatigue	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	3.3% 8/244 • Number of events 9 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
General disorders Influenza like illness	0.42% 1/240 • Number of events 1 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	6.6% 16/244 • Number of events 19 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Infections and infestations Nasopharyngitis	4.6% 11/240 • Number of events 12 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	4.5% 11/244 • Number of events 11 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 5/240 • Number of events 5 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	1.2% 3/244 • Number of events 3 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Musculoskeletal and connective tissue disorders Back pain	2.5% 6/240 • Number of events 6 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	1.2% 3/244 • Number of events 3 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.5% 6/240 • Number of events 8 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	4.9% 12/244 • Number of events 15 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	13.8% 33/240 • Number of events 56 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	14.8% 36/244 • Number of events 62 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.7% 4/240 • Number of events 4 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	1.2% 3/244 • Number of events 3 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	10.0% 24/240 • Number of events 42 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	9.8% 24/244 • Number of events 38 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Nervous system disorders Headache	4.2% 10/240 • Number of events 12 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	5.3% 13/244 • Number of events 14 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/240 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"	0.00% 0/244 • From Day 1 and up to 3 years. Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded. As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"

Additional Information

Disclosure

LEO Pharma A/S

Phone: +45 44945888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-centre publication within 18 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.
Publication restrictions are in place

Restriction type: OTHER