Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

Phase 1

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: LEO 43204; Drug: Placebo

• Registration Number: NCT02100813
• Lead Sponsor: LEO Pharma

Brief Summary

To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Study Start: 2014-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Disposition First Submitted: 2016-02-15
• Disposition First Submitted QC: 2016-02-15
• Disposition First Posted: 2016-03-14
• Status Verified: 2018-11
• Results First Submitted: 2018-11-14
• Results First Submitted QC: 2019-02-12
• Results First Posted: 2019-02-18
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• 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

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
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: LEO 43204	LEO 43204	Open-label, dose escalation, 2 days treatment
Part 2: LEO 43204 x dose	LEO 43204	X dose for 2 days treatment
Part 2: LEO 43204 Y dose	LEO 43204	Y dose for 2 days treatment
Part 2: Placebo	Placebo	Placebo for 2 days treatment

Primary Outcome Measures

Name	Time	Method
Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)	From Day 1 up to and including Day 8	The number participants experiencing a DLT was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants experiencing a DLT.; A DLT was defined as: * Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale; * Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT.; The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count	From baseline to Week 8	Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) in the selected treatment area.

Secondary Outcome Measures

Name	Time	Method
Part 2: Participants With Complete Clearance of AKs	From baseline to Week 8	Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in AK count.
Part 2: Participants With Partial Clearance of AKs	From baseline to Week 8	Partial clearance of AKs at Week 8 was defined as at least 75% reduction from baseline in AK count.

Trial Locations

Locations (1)

Gwinnett Clinical Research Center, Inc.; 🇺🇸 Snellville, Georgia, United States