Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil for Keloid
This study is evaluating whether a laser can help treat cancer.
See full descriptionAbout the trial for Keloid
Treatment Groups
This trial involves 2 different treatments. Fractional Erbium:YAG-assisted Drug Delivery Of 5-fluorouracil is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil will improve 2 primary outcomes and 1 secondary outcome in patients with Keloid. Measurement will happen over the course of 16 weeks.
Patient Q & A Section
What are common treatments for keloid?
There is little evidence supporting the use of topical ciclosporin, salidroside, or vitamin A derivatives as a treatment for keloids. More research is needed to explore potential benefits of newer agents such as topical quinacrine, salicylamide, tazarotene, or retinoids.
Has fractional erbium:yag-assisted drug delivery of 5-fluorouracil proven to be more effective than a placebo?
The clinical improvement was seen only to the treatment group, in which the dose of 5-FU had been reduced by 50%, compared with the placebo treated group, where no clinical benefits could have been observed.
Can keloid be cured?
Keloid is a chronic scarring wound whose appearance can be greatly altered by treatment. Keloid is a chronic wound in that it is a result of chronic, repeated irritation with minor scarring occurring within the second week following wounding. Keloid appears as an epidermal or dermal growth that seems to be a result of this trauma. It is a chronic scar. Keloid can be cured.
What causes keloid?
This disorder's cause is not understood. While, an association exists between keloids and drugs or the use of UV lamps, a causal relationship could not be established.
How many people get keloid a year in the United States?
In the U.S., over 3 million patients are diagnosed with some form of cutaneous keloid a year, making it the second most common benign cutaneous condition. The most common forms of cutaneous keloid are basal cell carcinoma (16%) and actinic keratosis (14%).
What is keloid?
Keloid tends to be characterized by the presence of nodules at the periphery and the overlying integument, usually occurring on the left shoulder or the back of the hands. The nodules are not always palpable and this condition can develop in anyone, but it is typically seen in people after the age of 40. The cause is unknown and no treatment is shown to help prevent its appearance or growth, but if present it can be treated by various topical methods. Keloids are uncommonly inherited in an autosomal-dominant manner, but familial predisposition to the disorder has not yet been proven. Keloid development is a complex process and can occur with or without an inflammatory trigger.
What are the signs of keloid?
Keloids may appear as lesions or as discoloration. Keloids may also turn out to be hypertrophic scars. There can be an association with diabetes and arthritis. Keloids may occur anywhere on the skin.\n
How does fractional erbium:yag-assisted drug delivery of 5-fluorouracil work?
5-FU was administered by this system in a large, high-fluence, local-tissue-targeting fashion, compared with 2- to 3-fold lower doses delivered by the same system via a transdermal route. In this way, fractional erbium:yag-assisted drug delivery significantly reduced systemic and local dosage, thus maximizing efficiency and safety of 5-FU treatment. Fractional erbium:yag-transdermal therapy may be a clinically applicable systemic antitumor therapy for which drug toxicity may be significantly reduced.
What does fractional erbium:yag-assisted drug delivery of 5-fluorouracil usually treat?
The FD@YAG is effective in depositing 5-FU at a site of interest. The precise mechanism of the FD@YAG technology is as follows: 1) the FD@YAG is able to form an emulsion, 2) the emulsion drops on the target due to the pressure difference, and 3) the droplet reacts with 5-FU.
What are the common side effects of fractional erbium:yag-assisted drug delivery of 5-fluorouracil?
Fraction fractionated ERb:YAG ALA-DFO-5-FU provides effective drug delivery for treatment of colorectal and other cancers. The application of fractionated ERb YAG ALA-DFO in combined drug applications significantly reduces side effect burden.
What is the average age someone gets keloid?
The mean patient age that keloids develop is 23 years. The mean age of people diagnosed with keloid is 58; thus, at presentation keloids should be considered in the differential diagnosis and diagnosed in a timely manner.
What are the latest developments in fractional erbium:yag-assisted drug delivery of 5-fluorouracil for therapeutic use?
The clinical and toxicological safety of a topical formulation of ytterbium-tetrachloride-erbium-yttrium borate (Yb:Yr:Er;YTB) nanoparticle gel in rabbits was demonstrated following multiple, one-month duration dosages. This formulation is a versatile, inexpensive, and sustained-release topical formulation of the 5-FU chemotherapy drug candidate YTB.