Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

LEO Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Actinic Keratosis

Treatments: Drug: Placebo; Drug: LEO 43204

Study type: Interventional

Funder types: Industry

Identifiers

NCT02120456

LP0084-1015

Details and patient eligibility

About

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
• Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 4 patient groups, including a placebo group

LEO 43204

Experimental group

Description:

Open-label, dose-escalation, 2-day treatment

Treatment:

Drug: LEO 43204

LEO 43204 Dose 0.1%

Experimental group

Description:

LEO 43204 dose 0.1% once daily for two consecutive days

Treatment:

Drug: LEO 43204

LEO 43204 Dose 0.075%

Experimental group

Description:

LEO 43204 dose 0.075% once daily for two days

Treatment:

Drug: LEO 43204

Placebo

Placebo Comparator group

Description:

Placebo once daily for two days

Treatment:

Drug: Placebo