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

Phase 3

Completed

• Conditions: Actinic Keratosis (AK)
• Interventions: Drug: Efudex®; Drug: Vehicle; Drug: 5-FU Cream

• Registration Number: NCT03727074
• Lead Sponsor: Sol-Gel Technologies, Ltd.

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.

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-01
• Study Start: 2018-12-21
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efudex®	Efudex®	topical cream
Vehicle	Vehicle	topical cream
5-FU Cream	5-FU Cream	topical cream

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Core Healthcare Group; 🇺🇸 Cerritos, California, United States