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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Picato® 0.05% gel

once daily for two consecutive days

Group Type ACTIVE_COMPARATOR

once daily for two consecutive days (Picato)

Intervention Type DRUG

ingenol mebutate vehicle formulation 1

once daily for two consecutive days

Group Type EXPERIMENTAL

once daily for two consecutive days (Picato)

Intervention Type DRUG

ingenol mebutate vehicle formulation 2

once daily for two consecutive days

Group Type EXPERIMENTAL

once daily for two consecutive days (Picato)

Intervention Type DRUG

ingenol mebutate vehicle formulation 3

once daily for two consecutive days

Group Type EXPERIMENTAL

once daily for two consecutive days (Picato)

Intervention Type DRUG

Interventions

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once daily for two consecutive days (Picato)

Intervention Type DRUG

Other Intervention Names

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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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No