CompletedPhase 1/2

Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis

United States395 participantsStarted 2013-04

Plain-language summary

To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
✓. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy

What they're measuring

Part 1: To Identify the Maximum Tolerated Dose (MTD) Levels After Once Daily Treatment for 2 or 3 Days

Timeframe: 8 days after initial treatment

Part 2: Number of Subjects With Complete Clearance of AKs

Timeframe: 8 weeks

Trial details

NCT IDNCT01820260

SponsorLEO Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-08

Results submitted2018-10-30

View on ClinicalTrials.gov More Actinic Keratosis trials