Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm
- Conditions
- Actinic Keratosis
- Interventions
- Drug: once daily for two consecutive days (Picato)
- Registration Number
- NCT01803477
- Lead Sponsor
- LEO Pharma
- Brief 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.
- Detailed Description
This study will be run in 2 parts. The first part involves applying escalating concentrations of the new vehicle formulations containing ingenol mebutate to AKs on the forearms. Reactions and safety will be compared to Picato® (a registered and marketed ingenol mebutate gel) to ascertain if the new vehicle formulations are at least as safe and effective as Picato® . The purpose of part 2 is to select the concentration in the "new formulation" that produces this same, if not better response, as Picato® and with a similar or better safety profile.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ingenol mebutate vehicle formulation 3 once daily for two consecutive days (Picato) once daily for two consecutive days ingenol mebutate vehicle formulation 1 once daily for two consecutive days (Picato) once daily for two consecutive days Picato® 0.05% gel once daily for two consecutive days (Picato) once daily for two consecutive days ingenol mebutate vehicle formulation 2 once daily for two consecutive days (Picato) once daily for two consecutive days
- Primary Outcome Measures
Name Time Method Safety of 3 new vehicle formulations containing ingenol mebutate compared to Picato® gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm 2 weeks Safety data to be collected via CRF entries of AEs/SAEs and photographs. Relative skin reactions for comparison to Picato®.
- Secondary Outcome Measures
Name Time Method Evaluate treatment responses on AK of selected concentration of ingenol mebutate containing vehicle formulation from Part 1 compared to Picato® gel as assessed by reduction in the number of selected AK lesions 2 months after treatment 2 months Assessed by visible and imaged lesion count
Trial Locations
- Locations (2)
Dermatology Department
🇦🇺Woolloongabba, Queensland, Australia
Specialist Connect
🇦🇺Woolloongabba, Queensland, Australia