Actinic Keratosis MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Picato®
Product Name: Ingenol mebutate gel
Pharmaceutical Form: Gel
INN or Proposed INN: Ingenol Mebutate
CAS Number: 75567-37-2
Other descriptive name: INGENOL MEBUTATE
Concentration unit
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 face or scalp. 3. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities. 4. Subject at least 18 years of age. 5. 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 trial treatment, to rule out pregnancy. 6. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion. Effective contraception is defined as follows: - Oral/implant/injectable/transdermal/oestrogenic vaginal ring contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide. - Abstinence or partner?s vasectomy are acceptable if the female agrees to implement one of the other acceptable methods of birth control if her partner changes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Location of the selected treatment areas: ? 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/scalp and on trunk/extremities. 3. Lesions in the selected treatment areas that have: ? atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or, ? recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions). 4. History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum). 5. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas. 6. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator?s clinical judgment. 7. Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications (see Exclusion Criteria Nos. 14-21). 8. Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel. 9. Presence of sunburn within the selected treatment areas. 10. Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial. 11. Subjects previously randomised in the trial. 12. Female subjects who are breastfeeding. 13. 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 evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face or scalp and the other located on trunk or extremities) are treated with ingenol mebutate gel. The primary response criterion is the composite Local Skin Reaction (LSR) score 3 days after treatment start of each selected treatment area.;Secondary Objective: To determine the efficacy and treatment satisfaction of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face or scalp and the other located on trunk or extremities) are treated with ingenol mebutate gel.;Primary end point(s): Composite LSR score 3 days after treatment start of each selected treatment area;Timepoint(s) of evaluation of this end point: 3 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? TSQM after a treatment cycle of 8 weeks, ? Complete clearance of AKs in each separate treatment area 8 weeks after treatment, ? Partial clearance of AKs in each separate treatment area 8 weeks after treatment, defined as 75% or greater reduction in AKs from start of treatment to 8 weeks after treatment, ? Percent reduction in number of AKs in each separate treatment area 8 weeks after treatment.;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Countries
Italy, Spain
Contacts
Public ContactFlorence Preaud
LEO PHARMA France
Outcome results
None listed