Clinical Study ProtocolSafety and efficacy of escalating doses of LEO 43204 applied once daily for two consecutive days on full balding scalp in subjects with actinic keratosis(sun spots)Part 1: A phase 1. Dose finding study. Follow-up period: 2-weeks Part 2: A phase 2, randomised, doubled, vehicle-controlled study. Follow up period: 8-weeks

Phase 1

• Conditions: Actinic Keratosis; MedDRA version: 17.0Level: 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: EUCTR2014-000037-23-DE
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-09
• Study Completion: 2015-03-02
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp.
Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp
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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

Location of the treatment area:
- within 5 cm of an incompletely healed wound
- within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)

Prior treatment with ingenol mebutate gel on the treatment area

Lesions in the treatment areas 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: Part 1: To identify the Maximum Tolerated Dose (MTD) of LEO 43204 after once daily treatment for two consecutive days.<br>Part 2: To evaluate efficacy of two doses of LEO 43204 given as once daily treatment for two consecutive days.;Secondary Objective: Part 1: To evaluate safety of LEO 43204 in escalating doses after once daily treatment for two consecutive days.<br>Part 2: To evaluate safety of two doses of LEO 43204 given as once daily treatment for two consecutive days.;Primary end point(s): Part 1 Dose Limiting Toxicity up to and including Day 8.<br>Part 2 Percent reduction in AK count from baseline to Week 8.;Timepoint(s) of evaluation of this end point: Part 1 8 days<br>Part 2 From baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Part 2: <br>Complete clearance of AKs at Week 8 <br>Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in AK count;Timepoint(s) of evaluation of this end point: Week 8