A Phase 1 Exploratory Trial Evaluating Safety and Tolerability of Topical Administration of Different Concentrations of an Ingenol Derivative Compared to Ingenol Mebutate Gel 0.05% Applied on Two Consecutive Days to Four Separate 25cm2 Treatment Areas on the Forearms of Subjects With Actinic Keratosis (Field Therapy)

NCT01703078 Phase 1 COMPLETED

The purpose of this study is to determine if the new ingenol derivative gels are as safe as and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for two consecutive days.

Details

Lead sponsor	LEO Pharma
Phase	Phase 1
Status	COMPLETED
Enrolment	41
Start date	2012-11
Completion	2013-04

Conditions

• Actinic Keratosis

Interventions

• Ingenol once daily for two consecutive days

Primary outcomes

• Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm — 8 weeks
  Safety data to be collected via CRF entries of AEs/SAEs and photographs.

Countries

Australia