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Completed

NCT Number: NCT03727074

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

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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Key information

Conditions

Actinic Keratosis (AK) Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Core Healthcare Group

Cerritos, California, 90703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

5-FU Cream

Drug

topical cream twice a day

Efudex®

Drug

topical cream twice a day

Vehicle

Drug

topical cream twice a day

Primary outcomes

  1. treatment success

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sol-Gel Technologies, Ltd.

Industry

Registry information

Official study title

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream, With Efudex® (5-FU) Cream, and Both Active Treatments to a Vehicle Control, in the Treatment of Actinic Keratosis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2018
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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