Actinic KeratosisPhase 3NCT02616601

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

A Phase 3 study testing Generic Fluorouracil Cream and Carac® (Fluorouracil) Cream in people with Actinic Keratosis, run by Actavis Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Actinic Keratosis
What is being tested?: Generic Fluorouracil Cream and Carac® (Fluorouracil) Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 422 participants
Where: 17 sitesUnited States
Study dates: 27 Feb 2015to 17 Sep 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 20Show fewer

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Investigative Site 15
Albuquerque, New Mexico
Investigative Site 1
Arlington Heights, Illinois
Investigative Site 5
Boise, Idaho
Investigative Site 11
Buffalo Grove, Illinois
Investigative Site 3
Carmel, Indiana
Investigative Site 8
Clinton Township, Michigan
Investigative Site 4
Denver, Colorado
Investigative Site 2
Fremont, California
Investigative Site 12
Fridley, Minnesota
Investigative Site 7
High Point, North Carolina
Investigative Site 16
Los Angeles, California
Investigative Site 10
Newnan, Georgia
Investigative Site 14
Philadelphia, Pennsylvania
Investigative Site 9
Plainfield, Indiana
Investigative Site 17
San Diego, California
Investigative Site 6
South Bend, Indiana
Investigative Site 13
Warren, Michigan

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Actinic Keratosis
Being tested: Generic Fluorouracil Cream, Carac® (Fluorouracil) Cream, Vehicle Cream
Medical subject headings: Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Generic Fluorouracil CreamDrug
Also called 5-FU
Topical cream, generic formulation of the brand product.
Carac® (Fluorouracil) CreamDrug
Also called 5-FU
Topical cream, brand product.
Vehicle CreamDrug
Topical cream, placebo. Has no active ingredient.

Study groups in NCT02616601
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 201517 Sep 2015

First posted30 Nov 2015 (estimated)
Study start27 Feb 2015
Primary completion17 Sep 2015
Study completion17 Sep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Actinic KeratosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 422 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02616601
Sponsor's protocol ID: 094-8251-301
Status last verified: Jun 2019
First submitted: 25 Nov 2015
Last updated: 17 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02616601
Acronym / sponsor ID: 094-8251-301
Conditions: Actinic Keratosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 422 participants (actual)
Lead sponsor: Actavis Inc.Industry (pharma, biotech, devices)
Study start: 27 Feb 2015 (actual)
Primary completion: 17 Sep 2015 (actual)
Study completion: 17 Sep 2015 (actual)
First posted: 30 Nov 2015 (estimated)
Results: Posted 17 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Generic Fluorouracil Cream	Experimental	Drug: Generic Fluorouracil CreamParticipants 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.
Carac® (Fluorouracil) Cream	Active comparator	Drug: Carac® (Fluorouracil) CreamParticipants 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.
Vehicle Cream	Placebo comparator	Drug: Vehicle CreamParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Generic Fluorouracil CreamAlso: 5-FUTopical cream, generic formulation of the brand product.	Drug	Generic Fluorouracil Cream
Carac® (Fluorouracil) CreamAlso: 5-FUTopical cream, brand product.	Drug	Carac® (Fluorouracil) Cream
Vehicle CreamTopical cream, placebo. Has no active ingredient.	Drug	Vehicle Cream

Primary outcome

Percentage of Participants With Treatment Success (Complete Clearance) at Week 6
Time frame: 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.

Results and safety

Results posted to the registry on 17 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Generic Fluorouracil Cream	140	131
Carac (Fluorouracil) Cream	140	136
Vehicle Cream	142	135

Primary outcome: Percentage of Participants With Treatment Success (Complete Clearance) at Week 6

Time frame: Week 6. Number. Unit: percentage of participants

Measure	Generic Fluorouracil Cream n = 112	Carac (Fluorouracil) Cream n = 121	Vehicle Cream n = 123
Value	33.9	33.9	3.3

Generic Fluorouracil Cream vs Carac (Fluorouracil) Cream: Mean Difference (Net): 0.04 (90% CI -11.03 to 11.11)
Generic Fluorouracil Cream vs Vehicle Cream: p <0.0001, Fisher Exact
Carac (Fluorouracil) Cream vs Vehicle Cream: p <0.0001, Fisher Exact

Population analysed: Participants in mlTT population who met inclusion/exclusion criteria, applied 75%-125% applications of study drug, did not miss applications for more than 3 consecutive days, no evidence of dosing noncompliance, and completed evaluation at Week 6 within ±4 days with no protocol violations that would affect treatment evaluation (PP Population).

Adverse events

Time frame: Baseline up to Week 6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Generic Fluorouracil Cream	4 of 140 (2.9%)	21 of 140 (15%)	1 of 140
Carac (Fluorouracil) Cream	1 of 140 (0.7%)	13 of 140 (9.3%)	0 of 140
Vehicle Cream	2 of 142 (1.4%)	9 of 142 (6.3%)	0 of 142

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Actavis Inc.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Generic Fluorouracil Cream and Carac® (Fluorouracil) Cream in people with Actinic Keratosis, run by Actavis Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment Success (Complete Clearance) at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.