Test Product (A): Fluorouracil Cream, 5% topical cream for Actinic Keratosis (AK)

Recruiting · 18+ · All Sexes · Cerritos, CA

Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis

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About the trial for Actinic Keratosis (AK)

Eligible Conditions
Actinic Keratosis (AK) · Keratosis, Actinic · Keratosis

Treatment Groups

This trial involves 3 different treatments. Test Product (A): Fluorouracil Cream, 5% Topical Cream is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Test Product (A): Fluorouracil Cream, 5% topical cream
Control Group 2
Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India
Control Group 3
Reference Product (B): Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reference Product (B): EFUDEX® (Fluorouracil 5%) Topical Cream of Bausch Health US, LLC, USA


This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Willing and able to provide voluntary informed consent and follow the protocol requirements
Males or females at least 18 years of age
Subjects with at least five (5) and no more than ten (10) clinically typical, visible, discrete, AK lesions, each at least 4 mm in diameter on the face or bald scalp. In this interpretation, if the total number of lesions on the face and bald scalp exceeds 10 and there are either 5-10 lesions on the face or 5-10 lesions on the bald scalp then select the designated treatment area that has 5-10 lesions (i.e., face or bald scalp)
Skin pigmentation (Fitzpatrick skin type I, II, and III) that will allow differentiation of erythema assessment
Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin)
Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double barrier method, oral, transdermal, injected, or implanted nonhormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
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Odds of Eligibility
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 weeks.
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Measurement Requirements

This trial is evaluating whether Test Product (A): Fluorouracil Cream, 5% topical cream will improve 3 primary outcomes and 1 secondary outcome in patients with Actinic Keratosis (AK). Measurement will happen over the course of 6 weeks.

Primary Efficacy End Point
The primary efficacy endpoint is the proportion of subjects in each treatment group with treatment success, defined as 100% clearance of all AK lesions (baseline or target AK lesions and any new AK lesions) within the designated treatment area (i.e., complete cure), assessed at study Week 6 (Day 43 ± 4, which is 4 weeks after completion of 2 weeks of treatment)
Superiority to Placebo
The superiority of the Test and Reference products against the Placebo product will be evaluated for the primary endpoint at Visit 4 in the modified Intent-to-Treat (mITT) population using the last observation carried forward (LOCF). If the proportion of subjects who are considered a complete cure in the Test and the Reference product groups is numerically and statistically superior to that of the Placebo (p < 0.05; using a two-sided Cochran-Mantel-Haenszel [CMH] test, stratified by clinical site), then the superiority of the Test and Reference products over Placebo will be concluded
Therapeutic equivalence with Reference product
Therapeutic equivalence will be evaluated for the primary endpoint at Visit 4 in the PP population. If the 90% confidence interval on the absolute difference between the proportion of subjects who are considered a complete cure in the Test and the Reference product groups (pT - pR) is contained within [-20%, +20%], then therapeutic equivalence of the Test product to the Reference product will be considered to have been demonstrated
Safety Analysis
All Safety analysis will be based on the Safety population. Adverse events will be classified using standard MedDRA terminology Version 24.0 or higher and summarized by treatment group. Summary tables comparing the type, incidence, date of onset, date of resolution, severity, action taken, outcome, and Investigator's opinion of relationship to the study product will be prepared by treatment group. If sufficient data exist, AE frequencies will be compared between treatments using Fisher's exact test. If the global Fisher's exact test is statistically significant among the three treatment groups at the 5% alpha level (i.e., p < 0.05), then Fisher's exact test using only the Test and Reference groups may be performed to identify any potential statistically significant differences that are clinically relevant between the two active treatment groups

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get actinic keratosis (ak) a year in the United States?

[actinic keratosis]( is the most common lesion of the skin in the United States. Of those lesions that will develop into squamous cell carcinoma, it is estimated that 75% will occur within the first 5 years after diagnosis. The most common age group for developing actinic keratosis is those aged 50 years and older. Women are more often than men afflicted. This condition is more common in those of non-Hispanic, non-white races. Skin disease is not limited to Caucasians. Although these data were derived from a limited number of hospitals, they help document the importance of early identification and treatment for this chronic disease. They offer insight into the demographics in which actinic keratosis would be diagnosed and treated.

Anonymous Patient Answer

What causes actinic keratosis (ak)?

The cause of actinic keratosis is not fully understood, but it is believed that the actinic hormone estrogen may play a small role. This condition occurs more often in women; it is associated with ultraviolet light exposure, usually excessive UVB exposure. It is associated with fair skin type.

Anonymous Patient Answer

What is actinic keratosis (ak)?

Actinic keratosis lesions develop and enlarge because epithelial cells at the surface of the skin are continually shed and replaced. After the cells that give abnormal epithelial appearance under an electron microscope are lost, the disease is called actinic keratosis. The signs and symptoms of actinic keratosis are a result of the loss of these normal epithelial cells. Actinic keratosis lesions are thought to be due to a combination of genetic factors and ultraviolet-B radiation from the sun, or sunlight.

Anonymous Patient Answer

What are the signs of actinic keratosis (ak)?

The most important sign in the diagnosis of AK is the age of the lesion: if it is atypical it is probably a precursor to SCC and should be biopsied. Other features can, individually, be helpful in the diagnosis, but a clinician may decide if they add to diagnostic uncertainty.

Anonymous Patient Answer

Can actinic keratosis (ak) be cured?

There is little evidence that AK can be cured. However, due to the lack of evidence, the evidence for AK being cured at all is very weak. Further well controlled studies are warranted to clarify a diagnosis of AK and to assess the treatment response of AK.

Anonymous Patient Answer

What are common treatments for actinic keratosis (ak)?

Overall prevalence of treatments for actinic keratosis is only 27% (n=946): 5% for shave procedures (n=244) and 22% for cryotherapy (n=599). Overall, 6% (n=21) underwent primary or secondary chemotherapy: 5% (n=19) with mitotane (n=7) and 3% (n=9) with 5-fluorouracil (5-FU), respectively. Sixty-seven percent (n=331) underwent primary cryotherapy, including 3% (n=12) with non-permanent methods and 63% (n=220) with permanent methods.

Anonymous Patient Answer

What is the latest research for actinic keratosis (ak)?

This article provides you with the latest research on [actinic keratosis]( (ak), not only by looking at the disease as a whole, but in its many variants as well. With this information, you can better manage your disease. Treatment should start with local treatment, such as removal of solar radiation by using an appropriate sunblock. After treatment, sunscreen should be worn constantly. Finally, if these treatments do not work, then treatment with topical vitamin D may be a good option. The latest research reveals that a group of medications called isotretinoin work better than UV light or vitamin D for treating PBC. The newer option may lead to less side effects for patients with PBC than previous treatments.

Anonymous Patient Answer

What are the common side effects of test product (a): fluorouracil cream, 5% topical cream?

The majority of common side effects in this placebo-controlled study indicate the potency of test product (a). We conclude that topical application of 5% fluorouracil cream results in an even more pronounced and intense therapeutic effect and a very low prevalence of side effects.

Anonymous Patient Answer

What does test product (a): fluorouracil cream, 5% topical cream usually treat?

Based on the literature and the survey results the most often used drug in topical treatments in Spain for cutaneous cancer are 5-FU, which has an important role in treatment of AK and 5-FU cream as the first choice for treatment.

Anonymous Patient Answer

Has test product (a): fluorouracil cream, 5% topical cream proven to be more effective than a placebo?

In a recent study, findings confirms that topical 5% FU is more effective (P > 0.05) than the placebo of the vehicle in the treatment of AK.

Anonymous Patient Answer

Does actinic keratosis (ak) run in families?

Ak has a strong genetic component, and familial AK seems to be a rare entity. The high frequency of familial AK argues against actinic keratoses being an orphan disease.

Anonymous Patient Answer

What is the average age someone gets actinic keratosis (ak)?

The average age someone gets AK when they've already had the disease is 62. The mean age where a patient has had AK is 61. The mean age when a patient is treated with the medication photodynamic therapy is 60. Overall, AK patients treated had average ages of 60 when they had the disease and 60 when they had the medication. Overall, AK patients who were treated for their disease averaged 62 and AK patients who had the medication averaged 64 when they had the disease and 56 when they had the medication. When it comes to the average age you'd get AK when you first get diagnosed, the range is from 45-72. That can range based on ethnicity. Overall, women were diagnosed younger when they have dark skin.

Anonymous Patient Answer
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