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

Sol-Gel Technologies

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis (AK)

Treatments: Drug: Vehicle; Drug: 5-FU Cream; Drug: Efudex®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03727074

SGT-19-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 462 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

462 participants in 3 patient groups, including a placebo group

5-FU Cream

Experimental group

Description:

topical cream

Treatment:

Drug: 5-FU Cream

Efudex®

Active Comparator group

Description:

topical cream

Treatment:

Drug: Efudex®

Vehicle

Placebo Comparator group

Description:

topical cream

Treatment:

Drug: Vehicle