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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/NCT01600014
Registration number
NCT01600014
Ethics application status
Date submitted
14/05/2012
Date registered
16/05/2012
Date last updated
9/05/2016
Titles & IDs
Public title
Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
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Scientific title
Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
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Secondary ID [1]
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2011-005018-13
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Secondary ID [2]
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LP0041-22
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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 mebutate gel, 0.015%
Treatment: Drugs - Vehicle gel
Active Comparator: Ingenol mebutate gel, 0.015% - Topical field treatment once daily for 3 consecutive days on the face or scalp
Placebo Comparator: Vehicle gel - Topical field treatment once daily for 3 consecutive days on the face or scalp
Treatment: Drugs: Ingenol mebutate gel, 0.015%
Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
Treatment: Drugs: Vehicle gel
Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
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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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Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation
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Assessment method [1]
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The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)
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Timepoint [1]
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8 weeks after randomisation
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Secondary outcome [1]
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Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12
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Assessment method [1]
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The analysis was done separately for the field recalcitrant subgroup, the field recurrent subgroup, and overall for all treated subject (Analysis 1, 2, and 3, respectively)
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Timepoint [1]
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From last treatment cycle through to Month 12
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Secondary outcome [2]
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The Change in AK Count From Randomisation to 8 Weeks After Randomisation
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Assessment method [2]
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The change in AK count from randomisation to 8 weeks after randomisation was determined for the field recalcitrant and the field recurrent subgroups
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Timepoint [2]
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8 weeks after randomisation
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Eligibility
Key inclusion criteria
- Subjects must provide informed consent
- Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous
25 cm2 treatment area on the face or scalp
- Subject at least 18 years of age
- Female subjects must be of either:
- Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical
history of sterility (e.g. the subject is without a uterus) or,
- Childbearing potential, provided there is a confirmed negative urine pregnancy
test prior to study treatment, to rule out pregnancy
- Female subjects of childbearing potential must be willing to consent to using highly
effective methods of contraception
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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:
- on any location other than the face or scalp
- on the periorbital skin
- within 5 cm of an incompletely healed wound
- within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma
(SCC)
- Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on
trunk and extremities acceptable)
- Selected treatment area lesions that have atypical clinical appearance
- History or evidence of skin conditions other than the trial indication that would
interfere with evaluation of the trial medication in the selected treatment area
- Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the
first treatment cycle
- Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
- Presence of sunburn within the selected treatment area
- Current enrollment or participation in a clinical trial within 30 days of entry into
this study
- Subjects previously entered first treatment in the trial
- Female subjects who are breastfeeding
- Subjects who are institutionalised by court order or by the local authority
- In the opinion of the investigator, the subject is unlikely to comply with the
Clinical Study Protocol
Prohibited Therapies and/or Medications within 2 weeks prior to Day 1
- Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
- Use of keratolytic topical therapeutic products within 2 cm of the selected treatment
area
- Use of topical medicated creams, ointments, lotions gels, foams or sprays within 2 cm
of the selected treatment area; artificial tanners: within 5 cm of the selected
treatment area
Prohibited Therapies and/or Medications: within 4 weeks prior to Day 1
- Treatment with immunomodulators, cytotoxic drugs or interferon /interferon inducers
- Treatment with systemic medications that suppress the immune system
- Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB)
Prohibited Therapies and/or Medications within 8 weeks prior to Day 1
- Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac sodium, or photodynamic
therapy: within 2 cm of the selected treatment area
Prohibited Therapies and/or Medications within 6 months prior to Day 1
- Use of systemic retinoids or biologic/monoclonal antibody therapies
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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 receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/05/2012
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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
1/02/2014
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Sample size
Target
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Accrual to date
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Final
463
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St John of God Dermatology - Subiaco
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Recruitment postcode(s) [1]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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Manitoba
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Country [4]
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Canada
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New Brunswick
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Country [5]
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Canada
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Ontario
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Country [6]
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Canada
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State/province [6]
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Quebec
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Country [7]
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France
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State/province [7]
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Loire-Atlantique 6
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Country [8]
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Germany
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State/province [8]
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Tübingen
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Country [9]
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United Kingdom
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State/province [9]
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Greater Manchester
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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 the study is to demonstrate that ingenol mebutate gel is efficacious in
treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in
a previously cleared field.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01600014
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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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Claus Garbe, MD
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Address
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University Hospital Tuebingen
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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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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/NCT01600014
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