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

Completed · Phase 3

Conditions studied: Actinic Keratosis (AK)

In brief

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.

Key facts

Study ID

NCT03727074

Run by

Sol-Gel Technologies, Ltd.

People needed

462

Starts

2018-12-21

Expected to finish

2019-12-19

Last updated by the study team

2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female 18 years of age and older.
• Subject is able to understand and willing to sign Institutional Review Board (IRB) approved written informed consent for this study.
• 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.
• 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.

You may not qualify if…

• Subject is pregnant, lactating, or is planning a pregnancy within the period of study participation.
• Subject suffers from excessive alcohol consumption, drug abuse or has a condition that could compromise the subject's ability to comply with study requirements.
• Presence of Atopic Dermatitis, Basal Cell Carcinoma, Eczema, Psoriasis, Rosacea, Squamous Cell Carcinoma or other possible confounding skin conditions on the

Where it is running

• Core Healthcare Group — Cerritos, California, United States

Full record on ClinicalTrials.gov

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