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

Primary Purpose

Actinic Keratosis (AK)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
5-FU Cream
Efudex®
Vehicle
Sponsored by
Sol-Gel Technologies, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis (AK) focused on measuring Actinic Keratosis ,AK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Core Healthcare Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

5-FU Cream

Efudex®

Vehicle

Arm Description

topical cream

topical cream

topical cream

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 30, 2018
Last Updated
March 17, 2020
Sponsor
Sol-Gel Technologies, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03727074
Brief Title
Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sol-Gel Technologies, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis (AK)
Keywords
Actinic Keratosis ,AK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
462 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-FU Cream
Arm Type
Experimental
Arm Description
topical cream
Arm Title
Efudex®
Arm Type
Active Comparator
Arm Description
topical cream
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
topical cream
Intervention Type
Drug
Intervention Name(s)
5-FU Cream
Intervention Description
topical cream twice a day
Intervention Type
Drug
Intervention Name(s)
Efudex®
Intervention Description
topical cream twice a day
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
topical cream twice a day
Primary Outcome Measure Information:
Title
treatment success
Description
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
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Core Healthcare Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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