Treatment of Actinic Keratoses with Ingenol Mebutate and topical glucocorticosteroid - a safety study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 21

Inclusion Criteria

•Age 18 or older
•Two eligible areas of 25 cm2 containing 4-20 AK lesions in the face or two eligible areas of 25 cm2 containing 4-20 AK lesions in the scalp
•Minimally four lesions in every area are Grade I or II (Grade I: Thin lesions, are better felt than seen, Grade II: Moderately thick, are easily seen and felt, Grade III Very thick and/or hyperkeratotik lesions)
•Fertile women must document non-reactive urine pregnancy test at the day of inclusion
•During the study fertile women must be using effective birth control. Effective contraception is defined as follows:
oInjectable or implantable hormones;
oIntrauterine device;
oTrans-abdominal surgical sterilization;
oSterilization implant device;
oSurgical sterilization of male partner;
oComplete abstinence from sexual intercourse for two weeks before exposure to study medication and throughout the clinical study
•Verbal and written consent to participate in the study
•Documentation of the medicine status

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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

•Non-melanoma skin cancer, Mb. Bowen or keratoacanthoma in the treatment area
•Previously treated with Ingenol Mebutate in the treatment area
•Tattoos, moles, or other active dermatological condition in the treatment area
•History of Psoriasis
•Medication with a systemic immunosuppressive, cytotoxic, immune modulating or retinoid agent within the last 3 months
•Use of topical applicants in the treated area that could interfere with the treatment or evaluation of the treatment the first 14 days, including commercially available day and night crèmes with retinoid agents
•Pregnant and breastfeeding women
•Patients that are considered incapable of complying with the protocol, i.e. patients suffering from dementia, alcoholism or psychiatric conditions