Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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