Evaluation of a Topical Treatment for Actinic Keratosis
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A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component.
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Ages Eligible for Study:
30 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Males or females 30 to 90 years old, inclusive, in good general health
Clinical diagnosis of Actinic Keratosis
At least 2 clinically diagnosed, 3-15 mm AK lesions on face or scalp
Patient is competent to understand and sign a consent form, and is willing and able to follow study procedures and attend all visits
Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication
Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
Pharmacologic methods of contraception should be stable for 1 month prior to Visit 1 and be maintained at same dose during the study
Patients who had been treated with: 5-FU, diclofenac, retinoids, ingenol mebutate or imiquimod within 4 weeks of study, immunomodulators, or interferon/interferon inducers or systemic immunosuppressants within 8 weeks of study, cryodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks of study, systemic cancer therapy, UVA therapy, UVB therapy, laser abrasion, dermabrasion
History of hereditary angio-edema, Epilepsy or Parkinson's Disease
Erythroderma or history of immunodeficiency disorders
Pregnancy, lactation or patient who is not practicing effective contraception
History of alcohol and drug abuse within 5 years of screening
Known hypersensitivity or previous allergic reaction to any of the components of the study medication
Having a member of the same household in the trial
Patient has participated in an investigational clinical, surgical, drug or device study within the past 30 days
Patients who in the opinion of the investigator should not be included in the study for any reason, including inability to follow procedures