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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 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

Thank you

Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

2 weeks

Safety Issue:

Yes

Principal Investigator

Lynda Spelman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Specialist Connect

Authority:

Australia: National Health and Medical Research Council

Study ID:

LP0085-1000

NCT ID:

NCT01803477

Start Date:

February 2013

Completion Date:

November 2013

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

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