Clinical trial NCT01600014: Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
Official title: Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2012-05-16
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation
timeFrame: 8 weeks after randomisation
Secondary outcomes:
measure: 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
timeFrame: From last treatment cycle through to Month 12
measure: The Change in AK Count From Randomisation to 8 Weeks After Randomisation
timeFrame: 8 weeks after randomisation
Other outcomes:
Locations:
city: Subiaco
country: Australia
facility: St John of God Dermatology
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Vancouver
country: Canada
facility: Skin Care Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: Moncton
country: Canada
facility: Durondel C.P. Inc./Dermatology Clinic
state: New Brunswick
city: Barrie
country: Canada
facility: UltraNova Skincare
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique
city: Nantes
country: France
facility: CHU de Nantes
state: Loire-Atlantique 6
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Manchester
country: United Kingdom
facility: Central Manchester University Hosptial
state: Greater Manchester
Study officials:
affiliation: University Hospital Tuebingen
name: Claus Garbe, MD
role: PRINCIPAL_INVESTIGATOR
References: