Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

Completed · Phase 3

Conditions studied: Actinic Keratosis

In brief

The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

Key facts

Study ID

NCT02361216

Run by

LEO Pharma

People needed

729

Starts

2015-04-01

Expected to finish

2017-03-01

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
• The full face
• The full balding scalp
• A contiguous area of approximately 250 cm2 on the chest

You may not qualify if…

• Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
• Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
• Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
• Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Where it is running

• Laser & Skin Surgery Center of Indiana — Carmel, Indiana, United States

Full record on ClinicalTrials.gov

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