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Completed

NCT Number: NCT01803477

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

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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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dermatology Department, Woolloongabba, Queensland, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

once daily for two consecutive days (Picato)

Drug

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

Primary outcomes

  1. 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

    Time frame: 2 weeks

    Safety data to be collected via CRF entries of AEs/SAEs and photographs. Relative skin reactions for comparison to Picato®.

Secondary outcomes

  1. 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

    Time frame: 2 months

    Assessed by visible and imaged lesion count

Other outcomes

  1. Safety of the new ingenol mebutate vehicle formulation (ascertained in Part 1) compared to Picato® gel applied topically once daily for 2 consecutive days to 4 separate treatment areas containing actinic keratosis on the forearm

    Time frame: 8 weeks

    Safety data to be collected via CRF entries of AEs/SAEs and photographs. Treatment responses assessed by Reflective confocal microscopy scoring of visible selected AK lesions

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2013
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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