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FRAXEL® LASER RECEIVES
FDA CLEARANCE FOR TREATMENT OF MELASMA
On July 27 2005, Reliant announced that the
Fraxel laser received FDA clearance to treat melasma, a stubborn
skin condition estimated to affect 6 million women worldwide. Until
now, melasma has been resistant to treatment, with traditional
laser and pulsed-light procedures considered unsatisfactory due
to lackluster results, significant downtime or the risk of adverse
complications.
“We are delighted to finally have
a successful laser treatment to offer patients who have been forced
to view the world and be viewed by the world through a mask that
could never be removed,” says dermatologist Cameron K. Rokhsar,
MD, of New York, NY, who authored a landmark paper on the topic. “With
the Fraxel laser’s unique approach of using millions of microscopic
thermal spots to gently resurface only portions of skin at a time,
we can now penetrate deep enough to eliminate the melanocytes that
cause melasma.”
Fraxel Laser
treatments for melasma have been producing phenomenal results. The Fraxel laser delivers a series of tiny and closely spaced laser beams to the skin while simultaneously preserving normal healthy skin between the laser spots.
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Before
Treatment |
After
4 Treatments |
Photographs
courtesy of Drs. Fitzpatrick & Rokhsar |
“We are delighted
to finally have a successful laser treatment to offer patients
who have been forced to view the world and be viewed by the
world through a mask that could never be removed.”
— Cameron K. Rokhsar,
MD
Dr. Rokhsar's study has been submitted
to the American Society of Dermatologic Surgeons for presentation
at their annual meeting in October and was accepted by Dermatologic
Surgery with a expected publication date of December. He joined
world renowned laser pioneer Dr. Richard Fitzpatrick in the ground
breaking study: “By employing fractional resurfacing with
its distinctive wound healing response, we can not only resolve
the excessive and undesirable pigmentation at the dermal junction,
but also avoid aggravating the surrounding melanocytes, preventing
inflammatory post-treatment responses,” explains Dr. Fitzpatrick.
| Fraxel® Laser
Clinical Data on Melasma
In the Fitzpatrick/Rokhsar
study, marked to significant improvement of melasma was
achieved in 60% of 10 female subjects as assessed by
independent investigators. Effectiveness was demonstrated
by improvement in the appearance of melasma and quality
of skin texture.
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Fraxel® Laser FDA Clearances
Dermatological procedures
requiring the coagulation of soft tissue
Treatment of periorbital wrinkles
Photocoagulation of pigmented lesions including lentigos (age spots),
solar lentigos (sun spots),
and dyschromia
Melasma
Skin resurfacing procedures |
Fraxel
Laser Treatment Results
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before
fraxel laser treatment
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after
fraxel laser
treatmant
courtesy
of Elizabeth Rostan
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before
fraxel laser treatment |
after
fraxel laser
treatmant
courtesy
of Yardy Tse
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What is melasma?
Melasma is a skin condition that mostly affects adult women with ethnic skin tones, and is often triggered by a hormonal change. It is estimated that roughly 6 million women suffer from this condition in the United States. Although anyone can be affected by melasma, it is most commonly seen in Asian, Hispanic, Hispanic, Middle Eastern, and African women. Melasma usually appears as patchy brown spots, typically on both sides of the face. It appears across the nose, cheeks, forehead, and upper lip. Only about ten percent of those affected by melasma are men.
Although the cause of melasma is still unknown, it seems that persons with a family history of melasma are more susceptible to developing the condition. Melasma is often triggered by a significant hormonal change like pregnancy and is sometimes called the “mask of pregnancy.” Other factors that can initiate the onset of melasma include birth control pills, sun exposure, and strong UV light exposure.
From a scientific standpoint, the process that develops melasma comes from the stimulation of pigment producing cells in the skin, called melanocytes. Because people with darker skin naturally have more melanocytes, the occurrence of melasma is much higher for this group. When a person who is already susceptible to melasma is exposed to the sun, the skin reacts by producing an excess amount of pigment.
How is it treated?
It is possible that melasma may disappear over time for some people, however, it can remain for many years after its onset. If the melasma arrived with the beginning of a birth control pill cycle, it may disappear by discontinuing the prescription. Right now, the most important weapon we have for the prevention of melasma is sunscreen. For those who have already developed melasma, it is crucial that sunscreen is worn all the time to prevent any kind of accidental exposure to UV light.
The laser delivers a series of microscopic closely spaced laser spots to the skin while simultaneously preserving normal healthy skin between the laser spots. This preservation of healthy skin results in rapid healing following the laser treatment. The entire face can be treated with the laser in approximately 30 minutes.
Aside from Fraxel, there are several other types of treatment are available for melasma. Assessment by a dermatologist will help you determine which method will be effective.
Bleaching creams do not technically "bleach" the melanocytes, but cause a decrease in activity of these pigment-producing cells. If you have only mild melasma, try for an over-the-counter cream first. These creams contain low concentrations of hydroquinone, which is a widely used depigmenting agent and is often effective for mild melasma when used twice daily.
With any of the creams, it takes about three months to see an improvement in melasma. With more severe cases, a dermatologist may prescribe creams with higher concentrations of hydroquinone. Other ingredients which may enhance the bleaching effect of the creams are tretinoin, steroids, and glycolic acid. Sunscreen is essential and comes combined with the bleaching cream in some products.
Two other medications which have been found to help melasma are azelaic acid and kojic acid. It is important to follow the directions of your dermatologist carefully in order to get the maximum benefit from your treatment regimen and to avoid irritation and other side effects. Other treatments which may or may not help in the treatment of melasma include chemical peels, microdermabrasion, and IPL, but results have not been consistent.
Only a doctor can help you to manage or eliminate melasma. If you suffer from melasma, help yourself by avoiding the sun and other skin irritants. |