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: 18.1Level: 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-DE
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-19
• Last Update Posted: 5 June 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:
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