A Phase 1 Exploratory Trial Evaluating Safety and Tolerability of Topical Administration of Different Concentrations of an Ingenol Derivative Compared to Ingenol Mebutate Gel 0.05% Applied on Two Consecutive Days to Four Separate 25cm2 Treatment Areas on the Forearms of Subjects With Actinic Keratosis (Field Therapy)
18 Years
N/A
Both
Actinic Keratosis
Trial Information
A Phase 1 Exploratory Trial Evaluating Safety and Tolerability of Topical Administration of Different Concentrations of an Ingenol Derivative Compared to Ingenol Mebutate Gel 0.05% Applied on Two Consecutive Days to Four Separate 25cm2 Treatment Areas on the Forearms of Subjects With Actinic Keratosis (Field Therapy)
Various concentrations of new ingenol derivatives will be applied to AKs on the forearms.
Reactions and safety will be compared to a US registered and marketed ingenol gel to
ascertain if the new ingenol is at least as safe and as well tolerated as the registered
ingenol.
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 Visit 2
- use of acid-containing therapeutic products within 2cm of the selected treatment area
in the 2 weeks prior to Visit 2
- use of topical moisturisers/creams/lotions, artificial tanners or topical steroids
within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment
with immunomodulators, or interferon/interferon inducers or systemic medications that
suppress the immune system within 4 weeks of Visit 2
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of
the treatment area in the 8 weeks prior to visit 2
- 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 of 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: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
Safety of a new ingenol derivative compared to ingenol mebutate 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.
Outcome Time Frame:
8 weeks
Safety Issue:
Yes
Principal Investigator
Hans P Soyer
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dermatology Department, Brisbane Public Hospital
Authority:
Australia: National Health and Medical Research Council
Study ID:
LP0084-68
NCT ID:
NCT01703078
Start Date:
November 2012
Completion Date:
April 2013
Related Keywords:
- Actinic Keratosis
- Keratosis
- Keratosis, Actinic
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