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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01803477
First received: February 28, 2013
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Drug: once daily for two consecutive days (Picato)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Safety data to be collected via CRF entries of AEs/SAEs and photographs. Relative skin reactions for comparison to Picato®.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assessed by visible and imaged lesion count


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 76
Study Start Date: February 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Picato® 0.05% gel
once daily for two consecutive days
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
Experimental: ingenol mebutate vehicle formulation 1
once daily for two consecutive days
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
Experimental: ingenol mebutate vehicle formulation 2
once daily for two consecutive days
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
Experimental: ingenol mebutate vehicle formulation 3
once daily for two consecutive days
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803477

Locations
Australia, Queensland
Specialist Connect
Woolloongabba, Queensland, Australia, 4102
Dermatology Department
Woolloongabba, Queensland, Australia, 4102
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Lynda Spelman, MD Specialist Connect
Principal Investigator: Hans P Soyer, MD Dermatology Department, Princess Alexandra Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01803477     History of Changes
Other Study ID Numbers: LP0085-1000
Study First Received: February 28, 2013
Last Updated: September 24, 2013
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014