CompletedPhase 3

A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

Italy200 participantsStarted 2013-02

Plain-language summary

The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate 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

Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area

Timeframe: 3 days after treatment of each selected treatment area

Trial details

NCT IDNCT01787383

SponsorLEO Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-01

Results submitted2014-12-18

View on ClinicalTrials.gov More Actinic Keratosis trials