Trial Review

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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/NCT01803477




Registration number
NCT01803477
Ethics application status
Date submitted
28/02/2013
Date registered
4/03/2013
Date last updated
10/09/2014

Titles & IDs
Public title
Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm
Scientific 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)
Secondary ID [1] 0 0
LP0085-1000
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 - once daily for two consecutive days (Picato)

Active Comparator: Picato® 0.05% gel - once daily for two consecutive days

Experimental: ingenol mebutate vehicle formulation 1 - once daily for two consecutive days

Experimental: ingenol mebutate vehicle formulation 2 - once daily for two consecutive days

Experimental: ingenol mebutate vehicle formulation 3 - once daily for two consecutive days


Treatment: Drugs: once daily for two consecutive days (Picato)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
2 months

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 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

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
Parallel
Other design features
Phase
Phase 1/Phase 2
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
1/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Dermatology Department - Woolloongabba
Recruitment hospital [2] 0 0
Specialist Connect - 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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01803477
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynda Spelman, MD
Address 0 0
Specialist Connect
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01803477