Actinic Keratosis (AK)
Conditions
Keywords
Actinic Keratosis ,AK
Brief summary
To compare the relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.
Detailed description
To compare the safety and efficacy profiles of 5-FU Cream with Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.
Interventions
DRUG5-FU Cream
topical cream twice a day
DRUGEfudex®
topical cream twice a day
DRUGVehicle
topical cream twice a day
Sponsors
Sol-Gel Technologies, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female 18 years of age and older. 2. Subject is able to understand and willing to sign Institutional Review Board (IRB) approved written informed consent for this study. 3. Subject must be generally healthy, based on medical records, and free from any clinically significant disease, other than AK, that in the opinion of the investigator might interfere with the study evaluations. 4. At least five (5) and no more than ten (10) clinically typical, visible or palpable, discrete AK lesions, each at least 4 mm in diameter on the face (excluding ears), forehead or bald scalp.
Exclusion criteria
1. Subject is pregnant, lactating, or is planning a pregnancy within the period of study participation. 2. Subject suffers from excessive alcohol consumption, drug abuse or has a condition that could compromise the subject's ability to comply with study requirements. 3. Presence of Atopic Dermatitis, Basal Cell Carcinoma, Eczema, Psoriasis, Rosacea, Squamous Cell Carcinoma or other possible confounding skin conditions on the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment success | week 6 | Proportion of subjects, in the Per-Protocol (PP) population, with treatment success, defined as complete clearing (100% clearance of all AK lesions within the designated treatment area) at the End of Study visit |
Countries
United States
Outcome results
None listed