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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
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)
Secondary ID [1] 0 0
LP0084-68
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
8 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Dermatology Department - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
LEO Pharma
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01703078
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hans P Soyer
Address 0 0
Dermatology Department, Brisbane Public Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries