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

Phase 3

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: LEO43204 gel; Drug: Vehicle gel

• Registration Number: NCT02549352
• Lead Sponsor: LEO Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Study Start: 2015-11
• Primary Completion: 2016-09-22
• Study Completion: 2017-08
• Disposition First Submitted: 2017-09-01
• Disposition First Submitted QC: 2017-09-01
• Disposition First Posted: 2017-09-06
• Results First Submitted: 2018-10-05
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-04
• Results First Posted: 2018-12-26
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

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 (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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 43204 gel	LEO43204 gel	Treatment once daily for 3 days
Vehicle gel	Vehicle gel	Treatment once daily for 3 days

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)	At Week 8	The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8.; Complete clearance was defined as no clinically visible AKs in the treatment area.; The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Partial Clearance	At Week 4	The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.; Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.; The table shows the percentage of mean number of participants across imputations with partial clearance at Week 4.
Percent Reduction in AK Count in the Treatment Area Compared to Baseline	At Week 8	The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.

Trial Locations

Locations (1)

Klinik für Dermatologie & Allergologie Klinikum Vest GmbH; 🇩🇪 Recklinghausen, Germany