OHSU

IRB #

IRB00010106

Title

Safety and efficacy of escalating doses of ingenol mebutate once daily for two or three consecutive days when used on full face, full balding scalp or approximately 250 cm2 on the chest in subjects with actinic keratosis
Part 1: A Phase 1, multicentre, open-label, dose escalation 2-week trial
Part 2: A Phase 2, multicentre, randomised, double-blind, parallel group,
vehicle-controlled, 8-week trial

Principal Investigator

Neil Swanson

Study Purpose

The purpose of this study is to determine the proper dose of Picato gel to use on an area larger than is currently approved by the FDA to treat actinic keratosis.

Medical Condition(s)

Actinic keratosis

Eligibility Criteria

18 years or older
5 to 20 AK's on either the face, scalp (if balding) or a 250 cm2 section of the chest

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Participation will last approximately 3 months and will involve about 7 visits to the clinic.

Minors Included

No

Contact

Maureen Keene 503-228-7350

Sponsor

Leo Pharma A/S

Recruitment End

10/11/2014

Compensation Provided

Yes

Compensation

You will receive $50 per visit for a total of up to $350. If you do not complete all visits, you will be paid only for the visits which you completed.


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