Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
- Conditions
- Actinic Keratosis
- Interventions
- Drug: Ingenol mebutate gel, 0.015%Drug: Vehicle gel
- Registration Number
- NCT01600014
- Lead Sponsor
- LEO Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 463
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Subjects must provide informed consent
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Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp
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Subject at least 18 years of age
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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
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Female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception
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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)
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Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on trunk and extremities acceptable)
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Selected treatment area lesions that have atypical clinical appearance
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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
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Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle
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Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
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Presence of sunburn within the selected treatment area
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Current enrollment or participation in a clinical trial within 30 days of entry into this study
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Subjects previously entered first treatment in the trial
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Female subjects who are breastfeeding
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Subjects who are institutionalised by court order or by the local authority
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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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ingenol mebutate gel, 0.015% Ingenol mebutate gel, 0.015% Topical field treatment once daily for 3 consecutive days on the face or scalp Vehicle gel Vehicle gel Topical field treatment once daily for 3 consecutive days on the face or scalp
- Primary Outcome Measures
Name Time Method Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation 8 weeks after randomisation 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)
- Secondary Outcome Measures
Name Time Method The Change in AK Count From Randomisation to 8 Weeks After Randomisation 8 weeks after randomisation The change in AK count from randomisation to 8 weeks after randomisation was determined for the field recalcitrant and the field recurrent subgroups
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 From last treatment cycle through to Month 12 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)
Trial Locations
- Locations (13)
Skin Care Centre
🇨🇦Vancouver, British Columbia, Canada
St John of God Dermatology
🇦🇺Subiaco, Australia
Stratica Medical
🇨🇦Edmonton, Alberta, Canada
Centre de Recherche Dermatologique
🇨🇦Quebec, Canada
Durondel C.P. Inc./Dermatology Clinic
🇨🇦Moncton, New Brunswick, Canada
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
Dermadvances Research
🇨🇦Winnipeg, Manitoba, Canada
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Windsor Clinical Research Inc.
🇨🇦Windsor, Ontario, Canada
UltraNova Skincare
🇨🇦Barrie, Ontario, Canada
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada
CHU de Nantes
🇫🇷Nantes, Loire-Atlantique 6, France
Central Manchester University Hosptial
🇬🇧Manchester, Greater Manchester, United Kingdom