Trial Outcomes & Findings for Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively (NCT NCT02305888)
NCT ID: NCT02305888
Last Updated: 2025-03-10
Results Overview
For face/chest, a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following five LSRs: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following four LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
8 days / From baseline (Day 1) to Day 8
Results posted on
2025-03-10
Participant Flow
Participant milestones
| Measure |
LEO 43204 0.018% Face/Chest
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
63
|
|
Overall Study
COMPLETED
|
63
|
62
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
LEO 43204 0.018% Face/Chest
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
Baseline characteristics by cohort
| Measure |
LEO 43204 0.018% Face/Chest
n=63 Participants
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
n=63 Participants
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
n=62 Participants
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
66.7 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
63 participants
n=7 Participants
|
62 participants
n=5 Participants
|
188 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 days / From baseline (Day 1) to Day 8For face/chest, a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following five LSRs: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following four LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3
Outcome measures
| Measure |
LEO 43204 0.018% Face/Chest
n=63 Participants
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
n=63 Participants
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
n=62 Participants
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
|---|---|---|---|
|
Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
|
9 Participants
|
0 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
Outcome measures
| Measure |
LEO 43204 0.018% Face/Chest
n=63 Participants
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
n=63 Participants
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
n=62 Participants
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
|---|---|---|---|
|
Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Week 4
|
81.2 percentage of reduction
Interval 74.7 to 86.1
|
78.8 percentage of reduction
Interval 71.6 to 84.1
|
59.0 percentage of reduction
Interval 50.0 to 66.3
|
|
Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Week 8
|
78.9 percentage of reduction
Interval 70.9 to 84.7
|
76.3 percentage of reduction
Interval 66.7 to 83.1
|
69.1 percentage of reduction
Interval 60.3 to 76.0
|
SECONDARY outcome
Timeframe: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8Population: For this efficacy analysis only participants with lesions identified as hypertrophic/hyperkeratotic at baseline were included in the analysis.
Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.
Outcome measures
| Measure |
LEO 43204 0.018% Face/Chest
n=9 Participants
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
n=10 Participants
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
n=16 Participants
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
|---|---|---|---|
|
Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Week 4
|
78.7 percentage of reduction
Interval 38.7 to 92.6
|
58.1 percentage of reduction
Interval 6.8 to 81.2
|
36.0 percentage of reduction
Interval 1.3 to 58.5
|
|
Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Week 8
|
68.5 percentage of reduction
Interval 4.5 to 89.6
|
62.5 percentage of reduction
Interval -13.2 to 87.5
|
39.2 percentage of reduction
Interval 7.9 to 59.9
|
SECONDARY outcome
Timeframe: 8 weeksComplete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
Outcome measures
| Measure |
LEO 43204 0.018% Face/Chest
n=63 Participants
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
n=63 Participants
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
n=62 Participants
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
|---|---|---|---|
|
Percentage of Participants With Complete Clearance of AKs
|
36.5 percentage of participants
Interval 24.7 to 49.6
|
39.7 percentage of participants
Interval 27.6 to 52.8
|
22.6 percentage of participants
Interval 12.9 to 35.0
|
Adverse Events
LEO 43204 0.018% Face/Chest
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
LEO 43204 0.037% Scalp
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
LEO 43204 0.1% Trunk/Extremities
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LEO 43204 0.018% Face/Chest
n=63 participants at risk
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
n=63 participants at risk
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
n=62 participants at risk
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
1.6%
1/63 • From baseline to Week 8±7 days
|
0.00%
0/63 • From baseline to Week 8±7 days
|
0.00%
0/62 • From baseline to Week 8±7 days
|
Other adverse events
| Measure |
LEO 43204 0.018% Face/Chest
n=63 participants at risk
Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.
|
LEO 43204 0.037% Scalp
n=63 participants at risk
Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.
|
LEO 43204 0.1% Trunk/Extremities
n=62 participants at risk
Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).
|
|---|---|---|---|
|
General disorders
Application site pain
|
44.4%
28/63 • From baseline to Week 8±7 days
|
54.0%
34/63 • From baseline to Week 8±7 days
|
41.9%
26/62 • From baseline to Week 8±7 days
|
|
General disorders
Application site pruritus
|
28.6%
18/63 • From baseline to Week 8±7 days
|
36.5%
23/63 • From baseline to Week 8±7 days
|
33.9%
21/62 • From baseline to Week 8±7 days
|
|
General disorders
Application site discomfort
|
1.6%
1/63 • From baseline to Week 8±7 days
|
1.6%
1/63 • From baseline to Week 8±7 days
|
3.2%
2/62 • From baseline to Week 8±7 days
|
|
Eye disorders
Periorbital oedema
|
3.2%
2/63 • From baseline to Week 8±7 days
|
4.8%
3/63 • From baseline to Week 8±7 days
|
3.2%
2/62 • From baseline to Week 8±7 days
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/63 • From baseline to Week 8±7 days
|
3.2%
2/63 • From baseline to Week 8±7 days
|
0.00%
0/62 • From baseline to Week 8±7 days
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
2/63 • From baseline to Week 8±7 days
|
0.00%
0/63 • From baseline to Week 8±7 days
|
0.00%
0/62 • From baseline to Week 8±7 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/63 • From baseline to Week 8±7 days
|
3.2%
2/63 • From baseline to Week 8±7 days
|
0.00%
0/62 • From baseline to Week 8±7 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/63 • From baseline to Week 8±7 days
|
4.8%
3/63 • From baseline to Week 8±7 days
|
1.6%
1/62 • From baseline to Week 8±7 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.6%
1/63 • From baseline to Week 8±7 days
|
0.00%
0/63 • From baseline to Week 8±7 days
|
3.2%
2/62 • From baseline to Week 8±7 days
|
|
Nervous system disorders
Headache
|
1.6%
1/63 • From baseline to Week 8±7 days
|
3.2%
2/63 • From baseline to Week 8±7 days
|
0.00%
0/62 • From baseline to Week 8±7 days
|
|
Psychiatric disorders
Insomnia
|
1.6%
1/63 • From baseline to Week 8±7 days
|
3.2%
2/63 • From baseline to Week 8±7 days
|
0.00%
0/62 • From baseline to Week 8±7 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/63 • From baseline to Week 8±7 days
|
3.2%
2/63 • From baseline to Week 8±7 days
|
0.00%
0/62 • From baseline to Week 8±7 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/63 • From baseline to Week 8±7 days
|
0.00%
0/63 • From baseline to Week 8±7 days
|
3.2%
2/62 • From baseline to Week 8±7 days
|
Additional Information
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