Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp

LEO Pharma

Status and phase: Completed; Phase 4

Conditions: Actinic Keratosis (AK)

Treatments: Drug: Diclofenac sodium gel 3%; Drug: Ingenol Mebutate Gel, 0.015%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02406014

LP0041-1120

Details and patient eligibility

About

This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.

Full description

All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp.

Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups:

• Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
• Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp

Exclusion criteria

1. Location of the selected treatment area:

• on the periorbital skin
• on the perioral skin/around the nostrils
• within 5 cm of an incompletely healed wound
• within 10 cm of a suspected BCC or SCC or other neoplasia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 2 patient groups

Treatment Group A

Active Comparator group

Description:

Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.

Treatment:

Drug: Ingenol Mebutate Gel, 0.015%

Treatment Group B

Active Comparator group

Description:

Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

Treatment:

Drug: Diclofenac sodium gel 3%