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
Interventions
Product Name: ingenol mebutate gel
Product Code: PEP005
Pharmaceutical Form: Gel
INN or Proposed INN: ingenol mebutate
CAS Number: 75567
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures 2. Subjects with 4 to 8 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, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, b. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy. 5. Female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception (Pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 1. 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) 2. Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on trunk and extremities acceptable). 3. Selected treatment area lesions that have atypical clinical appearance. 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 (e.g., eczema, psoriasis). 5. Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle. 6. Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel. 7. Presence of sunburn within the selected treatment area 8. Current enrolment or participation in a clinical trial within 30 days of entry into this study. 9. Subjects previously entered first treatment in the trial. 10. Female subjects who are breastfeeding. 11. Subjects who are institutionalised by court order or by the local authority 12. 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) The rest of exclusion criteria apply to prohibited therapies/medicines and are listed in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that ingenol mebutate gel is efficacious in treating AKs present 8 weeks after initial field treatment (field recalcitrant) or emerging in a previously cleared field (field recurrent). Efficacy will be evaluated separately for the two sub-groups of “field recalcitrant” and “field recurrent”. ; Secondary Objective: To demonstrate that ingenol mebutate gel repeat use shows a higher complete clearance rate at Month 12 compared with single use of ingenol mebutate gel plus vehicle gel use in patients with multiple AKs on face or scalp. To evaluate the safety profile of ingenol mebutate gel second use compared with ingenol mebutate gel first use in patients with multiple AKs on face or scalp. ;Primary end point(s): Complete clearance of AKs, defined as no clinically visible AKs in the selected treatment area, 8 weeks after randomisation.;Timepoint(s) of evaluation of this end point: Timepoint of evaluation is after completion of the Second Treatment Cycle, corresponding to 8 weeks after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 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. 2. Change in AK count in the selected treatment area from randomisation to 8 weeks after randomisation. 3. Adverse events occurring within first and second treatment cycles. 4. Change in composite LSR score at Day 4 between first and second ingenol mebutate gel treatment cycles ; Timepoint(s) of evaluation of this end point: Timepoint of evaluation: Regarding 1: Completion of the last treatment cycle at all visits through to Month 12 Regarding 2: At randomisation and at 8 weeks after randomisation Regarding 3: The period from Day 1 to Day 57 in a Treatment Cycle. Regarding 4: Day 4 in each Treatment Cycle. | — |
Countries
Australia, Canada, France, Germany, United Kingdom
Contacts
Public ContactInternational Clinical Development
LEO Pharma A/S
Outcome results
None listed