Actinic keratosis on the face or scalp MedDRA version: 18.1 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.Following verbal and written information about the trial, the 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 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
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) or recalcitrant disease (e.g., did not respond to AK treatment in the previous) 3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatmentarea 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, unstable psoriasis, xeroderma pigmentosum) 5. Use of ingenol mebutate and/or diclofenac sodium in and within 5 cm of the selected treatment area within the last 12 months prior to Visit 1 6. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment area 7. Known or suspected hypersensitivity or allergy to any of the ingredients in ingenol mebutate gel or diclofenac sodium gel 8. Organ transplant recipients 9. Immunosuppressed subjects (for example HIV patients) 10. 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 11. Presence of acute sunburn within the selected treatment area 12. Current enrolment or participation in a clinical trial within 30 days of entry into this trial 13. Subjects previously randomised in the trial 14. Female subjects who are breastfeeding 15. Subjects who are institutionalized by court order or by the local authority 16. 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 efficacy of daily application for 3 consecutive days of ingenol mebutate gel 0.015% with the efficacy of diclofenac sodium gel 3% for 90 days in subjects with AK on the face or scalp.;Secondary Objective: To compare the efficacy of up to two treatment courses of ingenol mebutate gel 0.015% (daily application for 3 consecutive days) with the efficacy of diclofenac sodium gel 3% for 90 days in subjects with AK on the face or scalp.;Primary end point(s): Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3%;Timepoint(s) of evaluation of this end point: Evaluation at week 8 for ingenol mebutate gel 0.015%. Evaluation at week 17 for diclofenac sodium gel 3%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As secondary response criteria, complete clearance at Week 17 for diclofenac sodium gel 3% will be compared with the following three measures of complete clearance in the ingenol mebutate 0.015% group: - Complete clearance of all AKs in the treatment field after one or two ingenol mebutate treatment courses. Subjects receiving only one treatment course are evaluated at Week 8 and subjects receiving two treatment courses are evaluated at Week 17. - Complete clearance of all AKs in the treatment field at Week 17 - Complete clearance of all AKs in the treatment field at Week 17 following only one ingenol mebutate treatment course. Subjects receiving a second ingenol mebutate treatment course are considered non-cleared.;Timepoint(s) of evaluation of this end point: Evaluation at week 17 for diclofenac sodium gel 3% (all secondary endpoints). For ingenol mebutate gel 0.015%: 1st secondary endpoint: Evaluation at week 8 for subjects receiving one treatment course, evaluation at week 17 for subjects receiving two treatment courses. 2nd secondary endpoint: Evaluation at week 17. 3rd secondary endpoint: Evaluation at week 17 for subjects receiving one treatment course, evaluation at week 8 for subjects receiving two treatment courses. | — |
Countries
Germany, Spain, United Kingdom
Contacts
Public ContactGlobal Clinical Operations
LEO Pharma GmbH
Outcome results
None listed