Trial | NCT01803477  Report issue

Title

Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm
A Seamless Phase 1/2 Exploratory Multi-centre, Investigator-blind, Dose Escalation Study (Study Part 1), Followed by a Randomised, Intra-subject, Active Controlled Efficacy Study of Different Ingenol Mebutate Formulations Applied to the Forearm for 2 Consecutive Days (Study Part 2)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ingenol mebutate ...

  • Study Participants

    37
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.
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.
Study Started
Feb 28
2013
Primary Completion
Oct 31
2013
Study Completion
Dec 31
2013
Last Update
Sep 10
2014
Estimate

Drug once daily for two consecutive days (Picato)

  • Other names: Picato® 0.05% gel, escalating doses of ingenol mebutate vehicle formulation 1, escalating doses of ingenol mebutate vehicle formulation 2, escalating doses of ingenol mebutate vehicle formulation 3

ingenol mebutate vehicle formulation 3 Experimental

once daily for two consecutive days

Picato® 0.05% gel Active Comparator

once daily for two consecutive days

ingenol mebutate vehicle formulation 1 Experimental

once daily for two consecutive days

ingenol mebutate vehicle formulation 2 Experimental

once daily for two consecutive days

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
No Results Posted