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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01703078
Registration number
NCT01703078
Ethics application status
Date submitted
5/10/2012
Date registered
10/10/2012
Date last updated
4/04/2013
Titles & IDs
Public title
Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis
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Scientific title
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)
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Secondary ID [1]
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LP0084-68
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis
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Condition category
Condition code
Skin
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Other skin conditions
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Skin
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ingenol once daily for two consecutive days
Active Comparator: Ingenol mebutate gel 0.05% - once daily for two consecutive days
Experimental: Ingenol derivative concentration 1 - once daily for two consecutive days
Experimental: Ingenol derivative concentration 2 - once daily for two consecutive days
Experimental: Ingenol derivative concentration 3 - once daily for two consecutive days
Treatment: Drugs: Ingenol once daily for two consecutive days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Safety data to be collected via CRF entries of AEs/SAEs and photographs.
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Timepoint [1]
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8 weeks
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Secondary outcome [1]
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Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment
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Assessment method [1]
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Assessed by Reflective Confocal Microscopy scoring of visible selected AK lesions
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Timepoint [1]
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8 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2013
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Sample size
Target
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Accrual to date
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Final
41
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Dermatology Department - Woolloongabba
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
LEO Pharma
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if the new ingenol derivative gels are as safe as
and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for
two consecutive days.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01703078
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Hans P Soyer
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Address
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Dermatology Department, Brisbane Public Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01703078
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