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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2019-12-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Actinic Keratosis (AK)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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5-FU Cream

topical cream

Group Type EXPERIMENTAL

5-FU Cream

Intervention Type DRUG

topical cream twice a day

Efudex®

topical cream

Group Type ACTIVE_COMPARATOR

Efudex®

Intervention Type DRUG

topical cream twice a day

Vehicle

topical cream

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

topical cream twice a day

Interventions

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5-FU Cream

topical cream twice a day

Intervention Type DRUG

Efudex®

topical cream twice a day

Intervention Type DRUG

Vehicle

topical cream twice a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No