Trial Outcomes & Findings for A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp (NCT NCT03115476)

Last Updated: 2025-03-11

Results Overview

Time to first squamous cell carcinoma (SCC) in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

563 participants

Primary outcome timeframe

From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months

Results posted on

2025-03-11

Participant Flow

1234 participants were randomised and applied investigational medicinal product (IMP) in the trials LP0084-1193, -1194, -1195, -1196 (main trials, Period 1). A total of 563 participants from the main trials continued and were enrolled into this extension follow-up trial (LP0084-1369, Period 2).

Participant milestones

Participant milestones
Measure	Ingenol Disoxate Gel 0.018% ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of actinic keratoses (AKs) on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Ingenol Disoxate Gel 0.037% ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of actinic keratoses AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Vehicle Gel Vehicle gel to Ingenol disoxate gel with no active ingredient
Main Trials (LP0084-119x) STARTED	407	418	409
Main Trials (LP0084-119x) COMPLETED	407	418	409
Main Trials (LP0084-119x) NOT COMPLETED	0	0	0
LP0084-1369 STARTED	191	210	162
LP0084-1369 COMPLETED	0	0	0
LP0084-1369 NOT COMPLETED	191	210	162

Reasons for withdrawal

Reasons for withdrawal
Measure	Ingenol Disoxate Gel 0.018% ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of actinic keratoses (AKs) on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Ingenol Disoxate Gel 0.037% ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of actinic keratoses AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Vehicle Gel Vehicle gel to Ingenol disoxate gel with no active ingredient
LP0084-1369 Death	1	0	2
LP0084-1369 Trial terminated by Sponsor	190	210	160

Baseline Characteristics

A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ingenol Disoxate Gel 0.018% n=191 Participants ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Ingenol Disoxate Gel 0.037% n=210 Participants ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Vehicle Gel n=162 Participants Vehicle gel of ingenol disoxate gel	Total n=563 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants	55 Participants n=7 Participants	43 Participants n=5 Participants	155 Participants n=4 Participants
Age, Categorical >=65 years	134 Participants n=5 Participants	155 Participants n=7 Participants	119 Participants n=5 Participants	408 Participants n=4 Participants
Age, Continuous	69 years n=5 Participants	71 years n=7 Participants	69 years n=5 Participants	70 years n=4 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	0 Participants n=7 Participants	30 Participants n=5 Participants	97 Participants n=4 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	210 Participants n=7 Participants	132 Participants n=5 Participants	466 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	182 Participants n=5 Participants	206 Participants n=7 Participants	162 Participants n=5 Participants	550 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	190 Participants n=5 Participants	209 Participants n=7 Participants	162 Participants n=5 Participants	561 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Canada	43 participants n=5 Participants	62 participants n=7 Participants	53 participants n=5 Participants	158 participants n=4 Participants
Region of Enrollment United States	98 participants n=5 Participants	104 participants n=7 Participants	70 participants n=5 Participants	272 participants n=4 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants	13 participants n=7 Participants	12 participants n=5 Participants	37 participants n=4 Participants
Region of Enrollment France	2 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment Germany	19 participants n=5 Participants	25 participants n=7 Participants	17 participants n=5 Participants	61 participants n=4 Participants
Region of Enrollment Spain	17 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants	23 participants n=4 Participants
Fitzpatrick skin type Type I	34 Participants n=5 Participants	26 Participants n=7 Participants	28 Participants n=5 Participants	88 Participants n=4 Participants
Fitzpatrick skin type Type II	109 Participants n=5 Participants	116 Participants n=7 Participants	94 Participants n=5 Participants	319 Participants n=4 Participants
Fitzpatrick skin type Type III	42 Participants n=5 Participants	54 Participants n=7 Participants	35 Participants n=5 Participants	131 Participants n=4 Participants
Fitzpatrick skin type Type IV	4 Participants n=5 Participants	13 Participants n=7 Participants	4 Participants n=5 Participants	21 Participants n=4 Participants
Fitzpatrick skin type Type V	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months

Population: Full Analysis Set: 1234 subjects who were randomised and applied IMP in one of 4 Main Trials

Outcome measures

Outcome measures
Measure	Ingenol Disoxate Gel 0.018% n=407 Participants ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Ingenol Disoxate Gel 0.037% n=418 Participants ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Vehicle Gel n=409 Participants Vehicle gel: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area	2.77 SCC events per 100 patient years Interval 1.55 to 4.57	0.88 SCC events per 100 patient years Interval 0.28 to 2.04	1.26 SCC events per 100 patient years Interval 0.46 to 2.74

SECONDARY outcome

Timeframe: From Visit 2 (6 months after Month 14 of main trial) to first SCC or other skin neoplasia in the treatment area, up to 24 months

Population: Full Analysis Set: 1234 subjects who were randomised and applied IMP in one of 4 Main Trials

Time to first squamous cell carcinoma (SCC) or other skin neoplasia in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis

Outcome measures

Outcome measures
Measure	Ingenol Disoxate Gel 0.018% n=407 Participants ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Ingenol Disoxate Gel 0.037% n=418 Participants ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Vehicle Gel n=409 Participants Vehicle gel: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area	10.24 SCC events per 100 patient years Interval 7.65 to 13.4	2.84 SCC events per 100 patient years Interval 1.62 to 4.61	3.19 SCC events per 100 patient years Interval 1.79 to 5.26

Adverse Events

Ingenol Disoxate Gel 0.018%

Serious events: 0 serious events

Other events: 16 other events

Deaths: 1 deaths

Ingenol Disoxate Gel 0.037%

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Vehicle Gel

Serious events: 0 serious events

Other events: 10 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Ingenol Disoxate Gel 0.018% n=191 participants at risk ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Ingenol Disoxate Gel 0.037% n=211 participants at risk ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Vehicle Gel n=161 participants at risk Vehicle gel: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/191 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.47% 1/211 • Number of events 1 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/161 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment

Other adverse events

Other adverse events
Measure	Ingenol Disoxate Gel 0.018% n=191 participants at risk ingenol disoxate gel 0.018%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Ingenol Disoxate Gel 0.037% n=211 participants at risk ingenol disoxate gel 0.037%: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.	Vehicle Gel n=161 participants at risk Vehicle gel: Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
General disorders Application site scar	4.2% 8/191 • Number of events 8 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	2.4% 5/211 • Number of events 5 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	4.3% 7/161 • Number of events 7 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment
General disorders Application site papules	0.52% 1/191 • Number of events 1 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/211 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/161 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.0% 2/191 • Number of events 2 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/211 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	1.9% 3/161 • Number of events 3 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.1% 4/191 • Number of events 4 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/211 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/161 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	1.6% 3/191 • Number of events 3 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/211 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.62% 1/161 • Number of events 1 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment
Injury, poisoning and procedural complications Inflammation of wound	0.52% 1/191 • Number of events 1 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/211 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/161 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/191 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.47% 1/211 • Number of events 1 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/161 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment
Injury, poisoning and procedural complications Scar	0.52% 1/191 • Number of events 1 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/211 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/161 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment
Skin and subcutaneous tissue disorders Rosacea	0.52% 1/191 • Number of events 1 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/211 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment	0.00% 0/161 • From first visit in this trial until the end of the trial i.e a period of up to 9 months as the trial was prematurely discontinued Only adverse events (AE) in the treatment area were collected, Serious AEs (SAE) outside treatment area were collected only if deemed related by the investigator to the study drug. This means that death not considered related to AEs in the treatment area is not included in the SAE table but are included in the All Course Mortality table For 1 subject the actual treatment was different from the planned treatment due to an error. Safety information is reported based on the actual treatment

Additional Information

Clinical Trial Disclosure

LEO Pharma

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER