Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp 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

NCT02100813

2014-000037-23 (EudraCT Number)

LP0084-1014

Details and patient eligibility

About

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

Enrollment: 220 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 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 4 patient groups, including a placebo group

Part 1: LEO 43204

Other group

Description:

Open-label, dose escalation, 2 days treatment

Treatment:

Drug: LEO 43204

Part 2: LEO 43204 x dose

Active Comparator group

Description:

X dose for 2 days treatment

Treatment:

Drug: LEO 43204

Part 2: LEO 43204 Y dose

Active Comparator group

Description:

Y dose for 2 days treatment

Treatment:

Drug: LEO 43204

Part 2: Placebo

Placebo Comparator group

Description:

Placebo for 2 days treatment

Treatment:

Drug: Placebo