Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-07-31

Brief Summary

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This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel

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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

DOUBLE

Participants Investigators

Study Groups

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2 days placebo and 2 days drug

Placebo and drug

Group Type EXPERIMENTAL

ingenol mebutate

Intervention Type DRUG

Placebo

Intervention Type OTHER

1 day placebo and 3 days drug

Placebo and drug

Group Type EXPERIMENTAL

ingenol mebutate

Intervention Type DRUG

Placebo

Intervention Type OTHER

4 days placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

4 days drug

Drug

Group Type EXPERIMENTAL

ingenol mebutate

Intervention Type DRUG

Interventions

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ingenol mebutate

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities

Exclusion Criteria

* Location of the treatment area (trunk (except chest) or extremities)

* 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 within the selected treatment area
* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No