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

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ClinicalTrials.gov Identifier: NCT03727074
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis (AK) Drug: 5-FU Cream Drug: Efudex® Drug: Vehicle Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5-FU Cream
topical cream
Drug: 5-FU Cream
topical cream twice a day

Active Comparator: Efudex®
topical cream
Drug: Efudex®
topical cream twice a day

Placebo Comparator: Vehicle
topical cream
Drug: Vehicle
topical cream twice a day




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727074


Contacts
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Contact: Ofra Levy-Hacham, Ph.D 972-8-9313433 ofra.levy-hacham@sol-gel.com

Locations
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United States, California
Core Healthcare Group Recruiting
Cerritos, California, United States, 90703
Contact: Mayracezl Rodriguez    562-924-8880    mrodriguezchg@gmail.com   
Principal Investigator: Francisco Badar, MD         
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.

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Responsible Party: Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT03727074     History of Changes
Other Study ID Numbers: SGT-19-01
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sol-Gel Technologies, Ltd.:
Actinic Keratosis ,AK
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs