Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

Criteria

Inclusion Criteria:

• Must be male or female and at least 18 years of age.

• Female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception.

• Ability to provide informed consent.

Exclusion Criteria:

• location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma

• undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit

• presence of sunburn within the selected treatment areas

• use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit

• previous enrolment in this clinical trial

• prior treatment with ingenol mebutate on the forearms

• use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit

• treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit

• treatment with 5-FU, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit

• use of systemic retinoids

• those who are currently participating in any other clinical trial

• females who are pregnant or are breastfeeding

• those known or suspected or not being able to comply with the requirements of the protocol or provide consent