Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis (sun spots) on Face or Chest including 12-month follow-up

Phase 1

• Conditions: Actinic Keratosis; MedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002450-12-IT
• Lead Sponsor: EO PHARMA A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-15
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the face or chest
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 153

Exclusion Criteria

-Location of the treatment area (full face or chest)
•within 5 cm of an incompletely healed wound
•within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (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. hypertrophic, hyperkeratotic or cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the efficacy of LEO 43204 gel (0.018% for face/chest) in AK when applied topically once daily for three consecutive days as field treatment;Secondary Objective: To evaluate the safety of LEO 43204 gel (0.018% in face/chest) in AK when applied topically once daily for three consecutive days as field treatment.<br>To evaluate the long term efficacy of LEO 43204 gel (0.018% for face/chest) in AK in an extended 12-month follow-up period after initial complete clearance at Week 8<br>;Primary end point(s): Complete clearance at Week 8, defined as no clinically visible AKs in the treatment area;Timepoint(s) of evaluation of this end point: Week 8

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Partial clearance at Week 8, defined as at least 75% reduction in the number of clinically<br>visible AKs in the treatment area<br>-Partial clearance at Week 4, defined as at least 75% reduction in the number of clinically<br>visible AKs in the treatment area<br>-Percent reduction in AK count in the treatment area at Week 8 compared to baseline;Timepoint(s) of evaluation of this end point: -Week 8<br>-Week 4<br>-Week 8