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/NCT01892137




Registration number
NCT01892137
Ethics application status
Date submitted
23/06/2013
Date registered
4/07/2013
Date last updated
5/04/2016

Titles & IDs
Public title
Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
Scientific title
Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
Secondary ID [1] 0 0
LP0041-62
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 mebutate gel 0.05%

Other: Open label active -


Treatment: Drugs: Ingenol mebutate gel 0.05%
Once daily for 2 consecutive days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clearance of AK
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Complete clearance of AKs in the Selected Treatment Area
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 on non-childbearing potential or if of childbearing potential
then negative serum and urine pregnancy test and using effective contraception

- Ability to provide informed consent

- Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a
contiguous 25cm2 treatment area on the trunk and extremities except the back of the
hand

- AK should be confirmed by histopathology of one of the AK's prior to inclusion
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 10cm of a suspected basal cell carcinoma or squamous cell carcinoma

- undergone Cosmetic or therapeutic procedures

- use of acid-containing therapeutic products within 2cm of the selected treatment area
in the 2 weeks prior to Visit 1

- use of topical creams/lotions, artificial tanners or topical steroids within 2cm of
the selected treatment areas in the 2 weeks prior to visit 1.

- treatment with immunomodulators, or interferon/interferon inducers or systemic
medications that suppress the immune system within 4 weeks of visit 1

- treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy
within 2cm of the treatment area in the 8 weeks prior to visit 1

- use of systemic retinoids

- those who are currently participating in any other interventional 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
N/A
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
Open (masking not used)
Who is / are masked / blinded?



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
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Southderm Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
Melanoma Institute Australia - north Sydney
Recruitment hospital [3] 0 0
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
South East Dermatology Centre - Carina Heights
Recruitment hospital [5] 0 0
St John of God Dermatology - Subiaco
Recruitment hospital [6] 0 0
Burswood Dermatology - Victoria Park
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2060 - north Sydney
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4152 - Carina Heights
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment postcode(s) [6] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Augsburg
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Bonn
Country [4] 0 0
Germany
State/province [4] 0 0
Stuttgart

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

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this trial is to demonstrate the predictive value of the clinical
diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using
histopathological examination as the standard.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01892137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martina Ulrich
Address 0 0
Collegium Medicum Berlin GmbH, Germany
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/NCT01892137