Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
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
1 other identifier
interventional
462
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2018
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedStudy Start
First participant enrolled
December 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2019
CompletedMarch 18, 2020
March 1, 2020
12 months
October 30, 2018
March 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
treatment success
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
week 6
Study Arms (3)
5-FU Cream
EXPERIMENTALtopical cream
Efudex®
ACTIVE COMPARATORtopical cream
Vehicle
PLACEBO COMPARATORtopical cream
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Core Healthcare Group
Cerritos, California, 90703, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
November 1, 2018
Study Start
December 21, 2018
Primary Completion
December 19, 2019
Study Completion
December 19, 2019
Last Updated
March 18, 2020
Record last verified: 2020-03