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

NCT02616601 | Completed Phase 3 Results

• 1 other identifier: 094-8251-301
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 17

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 6

Study Arms (3)

Generic Fluorouracil Cream

EXPERIMENTAL

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.

Drug: Generic Fluorouracil Cream

Carac® (Fluorouracil) Cream

ACTIVE COMPARATOR

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.

Drug: Carac® (Fluorouracil) Cream

Vehicle Cream

PLACEBO COMPARATOR

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.

Drug: Vehicle Cream

Interventions

Generic Fluorouracil Cream DRUG

Topical cream, generic formulation of the brand product.

Also known as: 5-FU

Generic Fluorouracil Cream

Carac® (Fluorouracil) Cream DRUG

Topical cream, brand product.

Also known as: 5-FU

Carac® (Fluorouracil) Cream

Vehicle Cream DRUG

Topical cream, placebo. Has no active ingredient.

Vehicle Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (17)

Investigative Site 2

Fremont, California, United States

Location

Investigative Site 16

Los Angeles, California, United States

Location

Investigative Site 17

San Diego, California, United States

Location

Investigative Site 4

Denver, Colorado, United States

Location

Investigative Site 10

Newnan, Georgia, United States

Location

Investigative Site 5

Boise, Idaho, United States

Location

Investigative Site 1

Arlington Heights, Illinois, United States

Location

Investigative Site 11

Buffalo Grove, Illinois, United States

Location

Investigative Site 3

Carmel, Indiana, United States

Location

Investigative Site 9

Plainfield, Indiana, United States

Location

Investigative Site 6

South Bend, Indiana, United States

Location

Investigative Site 8

Clinton Township, Michigan, United States

Location

Investigative Site 13

Warren, Michigan, United States

Location

Investigative Site 12

Fridley, Minnesota, United States

Location

Investigative Site 15

Albuquerque, New Mexico, United States

Location

Investigative Site 7

High Point, North Carolina, United States

Location

Investigative Site 14

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director, CE Studies
• Organization: Teva Pharmaceuticals Inc. USA

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Study Director

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: November 30, 2015
• Study Start: February 27, 2015
• Primary Completion: September 17, 2015
• Study Completion: September 17, 2015
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-06

Locations

US (17)