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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: LEO 43204

Open-label, dose escalation, 2 days treatment

Group Type OTHER

LEO 43204

Intervention Type DRUG

Part 2: LEO 43204 x dose

X dose for 2 days treatment

Group Type ACTIVE_COMPARATOR

LEO 43204

Intervention Type DRUG

Part 2: LEO 43204 Y dose

Y dose for 2 days treatment

Group Type ACTIVE_COMPARATOR

LEO 43204

Intervention Type DRUG

Part 2: Placebo

Placebo for 2 days treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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LEO 43204

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No