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Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Generic Fluorouracil Cream
Carac® (Fluorouracil) Cream
Vehicle Cream
Sponsored by
Actavis Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant is male and/or female, 18 years of age or older.
  • Participant is willing and able to give written informed consent.
  • Participant is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
  • Participant has a clinical diagnosis of actinic keratoses with at least 5 and no more than 10 clinically typical, visible or palpable, discrete, actinic keratoses (AK) lesions, each at least 4 millimeters (mm) in diameter on the face (excluding ears) or balding scalp.
  • Participant is in good general health and free of any disease state or physical condition that might impair evaluation of AK lesions or which, in the investigator's opinion, exposes the participant to an unacceptable risk by study participation.
  • Females must be post-menopausal, surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit.

Exclusion Criteria:

  • Participant is pregnant, lactating, or is planning to become pregnant during the study.
  • Participant is currently enrolled in an investigational drug or device study.
  • Participant has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
  • Participant has hyperkeratotic, hypertrophic, or large mat-like AK lesions (for example, an AK lesion >1 cm^2 in size) within the treatment area.
  • Participant has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
  • Participant is immunosuppressed (for example, human immunodeficiency virus (HIV), systemic malignancy, graft host disease)
  • Participant has experienced an unsuccessful outcome from previous topical fluorouracil therapy (an unsuccessful outcome is defined as after a reasonable therapeutic study with no compliance issues and the topical drug did not work).
  • Participant has a history of sensitivity to any of the ingredients in the test articles.
  • Participant has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
  • Participant used topical creams, lotions, or gels of any kind within the selected treatment area within 1 day prior to entry into the study.
  • Participant has used topical medications; corticosteroids, alpha hydroxy acids (for example, glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate; or prescription retinoids (for example, tazarotene, adapalene, tretinoin) within the selected treatment area (face or balding scalp) within 1 month prior to the Baseline Visit.
  • Participant has had cryodestruction, curettage, photodynamic therapy, surgical excision, or other treatments for AK within the selected treatment area (face or balding scalp) within 1 month prior to the Baseline Visit.
  • Participant has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within 1 month prior to the Baseline Visit.
  • Participant has had dermatologic procedures or surgeries such as: laser resurfacing, Psoralen + ultraviolet A (PUVA) therapy, ultraviolet B therapy, chemical peels, or dermabrasion within the selected treatment area (face or balding scalp) within 6 months prior to the Baseline Visit.
  • Participant has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or balding scalp).
  • Participant has any skin pathology or condition on the face or balding scalp that, in the Investigator's opinion, could interfere with the evaluation of the test article or requires the use of interfering topical, systemic, or surgical therapy.
  • Participant has any condition which, in the Investigator's opinion, would make it unsafe or preclude the participant's ability to fully participate in this research study.
  • Participant is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, impaired cerebral function, or physical limitations.
  • Participant is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (for example, due to alcoholism, drug dependency, mental incapacity) in the opinion of the Investigator.
  • Participant has been previously enrolled in the same study.

Sites / Locations

  • Investigative Site 2
  • Investigative Site 16
  • Investigative Site 17
  • Investigative Site 4
  • Investigative Site 10
  • Investigative Site 5
  • Investigative Site 1
  • Investigative Site 11
  • Investigative Site 3
  • Investigative Site 9
  • Investigative Site 6
  • Investigative Site 8
  • Investigative Site 13
  • Investigative Site 12
  • Investigative Site 15
  • Investigative Site 7
  • Investigative Site 14

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Generic Fluorouracil Cream

Carac® (Fluorouracil) Cream

Vehicle Cream

Arm Description

Participants are to apply up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone.

Participants are to apply up to 1 gram of Carac (fluorouracil) 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone.

Participants are to apply up to 1 gram of vehicle topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment Success (Complete Clearance) at Week 6
Percentage of participants with treatment success (complete clearance) at Week 6 (4 weeks after completion of 2 weeks of treatment). Complete clearance was defined as having no (zero) clinically visible actinic keratoses (AK) lesions in the treatment area at the Week 6/End Of Study visit. All AK lesions (baseline and new lesions) independent of size within the treatment area were treated and included in the efficacy lesion count.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2015
Last Updated
June 24, 2019
Sponsor
Actavis Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02616601
Brief Title
Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis
Official Title
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Fluorouracil Cream, 0.5% and Carac® (Fluorouracil) Cream, 0.5% in Subjects With Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 27, 2015 (Actual)
Primary Completion Date
September 17, 2015 (Actual)
Study Completion Date
September 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actavis Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.
Detailed Description
This is a multicenter, double-blind, vehicle-controlled, parallel group comparison study of a generic fluorouracil cream, 0.5% and Carac (fluorouracil) Cream, 0.5% in participants with actinic keratoses on the full face or balding scalp.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Generic Fluorouracil Cream
Arm Type
Experimental
Arm Description
Participants are to apply up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone.
Arm Title
Carac® (Fluorouracil) Cream
Arm Type
Active Comparator
Arm Description
Participants are to apply up to 1 gram of Carac (fluorouracil) 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone.
Arm Title
Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Participants are to apply up to 1 gram of vehicle topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone.
Intervention Type
Drug
Intervention Name(s)
Generic Fluorouracil Cream
Other Intervention Name(s)
5-FU
Intervention Description
Topical cream, generic formulation of the brand product.
Intervention Type
Drug
Intervention Name(s)
Carac® (Fluorouracil) Cream
Other Intervention Name(s)
5-FU
Intervention Description
Topical cream, brand product.
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
Topical cream, placebo. Has no active ingredient.
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success (Complete Clearance) at Week 6
Description
Percentage of participants with treatment success (complete clearance) at Week 6 (4 weeks after completion of 2 weeks of treatment). Complete clearance was defined as having no (zero) clinically visible actinic keratoses (AK) lesions in the treatment area at the Week 6/End Of Study visit. All AK lesions (baseline and new lesions) independent of size within the treatment area were treated and included in the efficacy lesion count.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant is male and/or female, 18 years of age or older. Participant is willing and able to give written informed consent. Participant is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study. Participant has a clinical diagnosis of actinic keratoses with at least 5 and no more than 10 clinically typical, visible or palpable, discrete, actinic keratoses (AK) lesions, each at least 4 millimeters (mm) in diameter on the face (excluding ears) or balding scalp. Participant is in good general health and free of any disease state or physical condition that might impair evaluation of AK lesions or which, in the investigator's opinion, exposes the participant to an unacceptable risk by study participation. Females must be post-menopausal, surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit. Exclusion Criteria: Participant is pregnant, lactating, or is planning to become pregnant during the study. Participant is currently enrolled in an investigational drug or device study. Participant has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit. Participant has hyperkeratotic, hypertrophic, or large mat-like AK lesions (for example, an AK lesion >1 cm^2 in size) within the treatment area. Participant has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study. Participant is immunosuppressed (for example, human immunodeficiency virus (HIV), systemic malignancy, graft host disease) Participant has experienced an unsuccessful outcome from previous topical fluorouracil therapy (an unsuccessful outcome is defined as after a reasonable therapeutic study with no compliance issues and the topical drug did not work). Participant has a history of sensitivity to any of the ingredients in the test articles. Participant has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. Participant used topical creams, lotions, or gels of any kind within the selected treatment area within 1 day prior to entry into the study. Participant has used topical medications; corticosteroids, alpha hydroxy acids (for example, glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate; or prescription retinoids (for example, tazarotene, adapalene, tretinoin) within the selected treatment area (face or balding scalp) within 1 month prior to the Baseline Visit. Participant has had cryodestruction, curettage, photodynamic therapy, surgical excision, or other treatments for AK within the selected treatment area (face or balding scalp) within 1 month prior to the Baseline Visit. Participant has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within 1 month prior to the Baseline Visit. Participant has had dermatologic procedures or surgeries such as: laser resurfacing, Psoralen + ultraviolet A (PUVA) therapy, ultraviolet B therapy, chemical peels, or dermabrasion within the selected treatment area (face or balding scalp) within 6 months prior to the Baseline Visit. Participant has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or balding scalp). Participant has any skin pathology or condition on the face or balding scalp that, in the Investigator's opinion, could interfere with the evaluation of the test article or requires the use of interfering topical, systemic, or surgical therapy. Participant has any condition which, in the Investigator's opinion, would make it unsafe or preclude the participant's ability to fully participate in this research study. Participant is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, impaired cerebral function, or physical limitations. Participant is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (for example, due to alcoholism, drug dependency, mental incapacity) in the opinion of the Investigator. Participant has been previously enrolled in the same study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Actavis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site 2
City
Fremont
State/Province
California
Country
United States
Facility Name
Investigative Site 16
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Investigative Site 17
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigative Site 4
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Investigative Site 10
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
Investigative Site 5
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Investigative Site 1
City
Arlington Heights
State/Province
Illinois
Country
United States
Facility Name
Investigative Site 11
City
Buffalo Grove
State/Province
Illinois
Country
United States
Facility Name
Investigative Site 3
City
Carmel
State/Province
Indiana
Country
United States
Facility Name
Investigative Site 9
City
Plainfield
State/Province
Indiana
Country
United States
Facility Name
Investigative Site 6
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
Investigative Site 8
City
Clinton Township
State/Province
Michigan
Country
United States
Facility Name
Investigative Site 13
City
Warren
State/Province
Michigan
Country
United States
Facility Name
Investigative Site 12
City
Fridley
State/Province
Minnesota
Country
United States
Facility Name
Investigative Site 15
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Investigative Site 7
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Investigative Site 14
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis

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