Official Title

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

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    leo 43204 ...
  • Study Participants

    373
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.
Study Started
Nov 30
2015
Primary Completion
Aug 17
2016
Study Completion
Aug 31
2017
Results Posted
Dec 26
2018
Last Update
Dec 26
2018

Drug LEO 43204 gel

  • Other names: Ingenol Disoxate

Drug Vehicle gel

LEO 43204 Experimental

Treatment once daily for 3 days

Vehicle gel Placebo Comparator

Treatment once daily for 3 days

Criteria

Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area

Exclusion Criteria:

Location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
Treatment with ingenol mebutate gel in the treatment area within the last 12 months
Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)

Summary

LEO 43204 0.037% Gel

Vehicle Gel

LEO 43204 0.037% Gel - Extended Follow-up

Vehicle Gel - Extended Follow-up

All Events

Event Type Organ System Event Term LEO 43204 0.037% Gel Vehicle Gel LEO 43204 0.037% Gel - Extended Follow-up Vehicle Gel - Extended Follow-up

Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)

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.

LEO 43204 0.037% Gel

25.8
percentage of participants
95% Confidence Interval: 20.4 to 32.2

Vehicle Gel

Percentage of Participants With Partial Clearance of AKs

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

LEO 43204 0.037% Gel

58.9
percentage of participants
95% Confidence Interval: 52.1 to 65.3

Vehicle Gel

1.0
percentage of participants
95% Confidence Interval: 0.2 to 5.2

Percentage of Participants With Partial Clearance of AKs

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

LEO 43204 0.037% Gel

57.4
percentage of participants
95% Confidence Interval: 50.6 to 63.9

Vehicle Gel

1.0
percentage of participants
95% Confidence Interval: 0.2 to 5.2

Percent Reduction in AK Count in the Treatment Area Compared to Baseline

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.

LEO 43204 0.037% Gel

72.3
percentage of reduction (Mean)
95% Confidence Interval: 69.1 to 75.2

Vehicle Gel

-2.0
percentage of reduction (Mean)
95% Confidence Interval: -16.0 to 10.3

Total

313
Participants

Age, Continuous

70.5
years (Mean)
Standard Deviation: 9.2

Age, Customized

Region of Enrollment

Sex: Female, Male

3-day Treatment and 8-week Follow-up

LEO 43204 0.037% Gel

Vehicle Gel

12-month Follow-up

LEO 43204 0.037% Gel

Vehicle Gel

Drop/Withdrawal Reasons

LEO 43204 0.037% Gel

Vehicle Gel