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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
Secondary ID [1] 0 0
2011-005018-13
Secondary ID [2] 0 0
LP0041-22
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, 0.015%
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%
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation
Timepoint [1] 0 0
8 weeks after randomisation
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From last treatment cycle through to Month 12
Secondary outcome [2] 0 0
The Change in AK Count From Randomisation to 8 Weeks After Randomisation
Timepoint [2] 0 0
8 weeks after randomisation

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
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:

* 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

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 receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
463
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St John of God Dermatology - Subiaco
Recruitment postcode(s) [1] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
France
State/province [7] 0 0
Loire-Atlantique 6
Country [8] 0 0
Germany
State/province [8] 0 0
Tübingen
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Greater Manchester

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01600014
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claus Garbe, MD
Address 0 0
University Hospital Tuebingen
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/study/NCT01600014