Actinic keratosis on the face and scalp MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed Informed Consent Form (ICF) prior to any trial-related procedures 2.Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp. 3.Subject at least 18 years of age 4.Female subjects must be of either: a.Non-childbearing potential, or, b.Childbearing potential, provided there is a confirmed negative urine pregnancy test 5.Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 384
Exclusion criteria
Exclusion criteria: 1.Location of the selected treatment area: •on the periorbital skin •on the perioral skin/around the nostrils •within 5 cm of an incompletely healed wound •within 10 cm of a suspected BCC or SCC or other neoplasia 2.Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn). 3.History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area. 4.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 5.Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1) 6.Organ transplant recipients 7.Immunosuppressed subjects (for example HIV patients) 8.Female subjects who are breastfeeding. 9.Subjects who are institutionalised by court order or by the local authority 10.In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the cumulative incidence of squamous cell carcinoma (SCC) after treatment with ingenol mebutate gel and imiquimod cream.;Secondary Objective: To compare the cumulative incidence of neoplasia and the short-term and 12-month efficacy of ingenol mebutate gel with imiquimod cream.;Primary end point(s): Diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period;Timepoint(s) of evaluation of this end point: Completion of the 3 year trial period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Diagnosis of SCC and other neoplasia in the treatment field over a 3-year period. 2.Complete clearance after the last treatment cycle (at Week 8 or 16) 3.Partial (at least 75%) clearance after the last treatment cycle (at Week 8 or 16) 4.Complete clearance at 12 months, defined as no AKs in the selected treatment area at any time from the last treatment cycle at Week 8 or 16 through to Month 12. ;Timepoint(s) of evaluation of this end point: Timepoint of evaluation: Regarding 1: Completion of the 3 year trial period. Regarding 2: Completion of the last treatment cycle (week 8 or 16) Regarding 3: Completion of the last treatment cycle (week8 or 16) Regarding 4: At 12 months | — |
Countries
France, Germany, United Kingdom
Contacts
Public ContactGlobal Clinical Operations
LEO Pharma A/S
Outcome results
None listed