CLINICAL TRIAL

Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil for Keloid

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether a laser can help treat cancer.

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About the trial for Keloid

Eligible Conditions
Keloid · Keloids Scars

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.

Experimental Group 1
Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
COMBINATIONPRODUCT
Experimental Group 2
Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
COMBINATIONPRODUCT

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The keloid has been present for at least 1 year. show original
Age 18-89
The individual has at least two keloid scars, each about the size of a dime. show original
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Odds of Eligibility
Unknown<50%
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: 16 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 16 weeks.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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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.

Modified Hamilton score of Site A and Site B
16 WEEKS
Obtained by comparing clinical photographs of the scarred skin and healthy skin next to each other in Site A and Site B. The Hamilton scale consists of 4 items with a score range of 0 to 14 where 14 represents more severe scarring.
16 WEEKS
Change in scar measurements of sites A and B of the keloid treated with laser-assisted 5-FU versus laser-assisted TAC
16 WEEKS
The measurements will be calculated as the total volume (length x width x height) in cm3 of the scar, or length x width in cm2 if the scars are flush with the surrounding skin scar surface
16 WEEKS
Change in POSAS score in Site A and Site B at first visit (pre-treatment) versus last visit (post-treatment)
16 WEEKS
The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale.
16 WEEKS

Patient Q & A Section

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

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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%).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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