Overview

Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream

Status:
Completed
Trial end date:
2019-12-19
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sol-Gel Technologies, Ltd.
Treatments:
Fluorouracil
Criteria
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