Test Product (A): Fluorouracil Cream, 5% topical cream for Actinic Keratosis (AK)
Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis
See full descriptionAbout the trial for Actinic Keratosis (AK)
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.
Eligibility
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.
Approximate Timelines
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.
Patient Q & A Section
How many people get actinic keratosis (ak) a year in the United States?
[actinic keratosis](https://www.withpower.com/clinical-trials/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.
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.
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.
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.
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.
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.
What is the latest research for actinic keratosis (ak)?
This article provides you with the latest research on [actinic keratosis](https://www.withpower.com/clinical-trials/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.
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.
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.
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.
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.
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.