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

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Other: Placebo; Drug: ingenol mebutate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01998984

LP0105-1020

Details and patient eligibility

About

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

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 4 patient groups, including a placebo group

2 days placebo and 2 days drug

Experimental group

Description:

Placebo and drug

Treatment:

Drug: ingenol mebutate

Other: Placebo

1 day placebo and 3 days drug

Experimental group

Description:

Placebo and drug

Treatment:

Drug: ingenol mebutate

Other: Placebo

4 days placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

4 days drug

Experimental group

Description:

Drug

Treatment:

Drug: ingenol mebutate