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

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 Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Vehicle gel; Drug: LEO43204 gel

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Recklinghausen, Germany, 45657
    • Klinik für Dermatologie & Allergologie Klinikum Vest GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 43204 gel; Treatment once daily for 3 days	Drug: LEO43204 gel; Other Names: Ingenol Disoxate
Placebo Comparator: Vehicle gel; Treatment once daily for 3 days	Drug: Vehicle gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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), 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.	At Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.	At Week 8
Percentage of Participants With Partial Clearance	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 8.	At Week 8
Percentage of Participants With Partial Clearance	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.	At Week 4

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Rolf-Markus Szeimies, Prof. Dr.med, Klinik für Dermatologie & Allergologie Klinikum Vest GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 22, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: LP0084-1196