Efficacy and Safety of a New Topical Formulation With Imiquimod (Limtop) Applied 1, 3 or 7 Times Weekly During 2 x 2 Weeks Treatment for Actinic Keratosis on the Head
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Written informed consent form (ICF) signed and dated by the patient prior to any study-related activity
Male or female patients aged 18 or older
Have a total of 5-20 clinically confirmed, palpable or visible (grade I or II according to modified Olsen score) nonhyperkeratotic, nonhypertrophic AK lesions located within a contiguous 25 - 100 cm² area on the balding scalp or face
Any skin type or race, providing the skin pigmentation will allow discernment of erythema
Willingness to actively participate in the study and to comply with the study procedures as defined in the study protocol
High probability of a good compliance and orderly completion of the study
Negative urine pregnancy test (in female subjects with childbearing potential)
Evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease
Diagnosed autoimmune diseases and anaemia
Any dermatological disease and or condition in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (e.g. rosacea, psoriasis, atopic dermatitis, eczema)
Any significant findings (e.g. tattoos) in the potential application site area that may impair examination of treatment or surrounding area
Confirmed squamous cell or basal cell carcinoma anywhere on the head in the past 3 months
Share a household where there is a person participating in a concurrent clinical study of imiquimod or being treated with imiquimod 5% topical cream
Active chemical dependency or alcoholism, as assessed by investigator
Patients unwilling to stay out of the sun or wear protective clothing or to take appropriate measures to cover the treatment area during the study
Previous treatments with imiquimod for AK in the predetermined treatment area within the past 3 months
Treatment with COX-2 inhibitors 14 days prior to randomization
Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization
Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
Known allergy or sensitivity to imiquimod or any of the excipients (butyl lactate, isopropyl myristate, propylene glycol, butylated hydroxy anisole) in the IMP
Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who:
are pregnant or nursing,
are not surgically sterile,
are of child bearing potential and not practicing an acceptable method of birth control, or does not plan to continue practicing an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)
Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before Baseline
Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry.
Currently using or have used systemic steroids 2 months prior to study except inhaled corticosteroids (<1200 microgram/day for beclomethasone, or <600 microgram/day for fluticasone)
Known infectious diseases (e.g. HIV, hepatitis)
Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
The Patient is institutionalized by virtue of an order issued either by the judicial or the administrative authorities
Employee of the study site or of the Sponsor's company
Any disease or circumstances on account of which the subject should not participate in the study in the opinion of the investigator -