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Over the past several years, over-the-counter (OTC) cosmetic laser and light devices have been introduced and aggressively promoted for consumer home use. On late night infomercials, in tabloid magazines, online, through various healthcare related venues—seems as if they are everywhere. Neat devices that promise to remove wrinkles at home, zit-zappers that get rid of that pimple by happy hour, grow hair—remove hair, take your pick. As a cosmetic dermatologist, I am often asked my opinion about these devices, if they work and if they are worth it.

There are 3 criteria to consider that will help you make the decision whether home laser and light treatments make sense for you: Is it safe? Is it effective? Are the results worth the money?

There are obvious advantages for consumers when compared with in-office treatments, most prominently the ability to perform treatments at home, and for potentially less cost than professional office based treatments. On the other hand, these devices are much less powerful than comparable office based lasers and light treatments, both to make them affordable to consumers and to allow them to be safely used by non-medical operators. This results in the need for a greater number of treatments, longer treatment times, and less effective treatments.

If you are considering using one of the devices, you do need to consider the way these home devices are regulated by the Food and Drug Administration (FDA) so that you are not misled on their safety and efficacy. Devices are equipment, and the FDA classifies medical devices based on the risks associated with using the device. Devices are classified into one of three categories—Class I, Class II, and Class III.

Drugs and serious high-tech medical devices such as implantable heart defibrillators are Class III devices and must always be “approved” after going through serious testing to establish both safety and effectiveness. Less-invasive medical equipment falls into Class II. This is a broad category, as it includes some hospital and office use medical devices as well as some home use devices such as home skin laser devices and wheelchairs.

Class II devices may be “approved” or “cleared.” “Cleared” Class II medical devices are ones that FDA has determined to be “substantially equivalent” in mechanism to another legally marketed device, whether or not that device actually works, and is not an indication that the cleared device has been proven effective. Home skin lasers, if they have any FDA certification, fall into the cleared category. An “approved” Class II medical device has gone through a much more rigorous process demonstrating both safety and efficacy, and is used for the more high risk devices in this category such as medical use skin lasers. Class I devices are very low risk devices, such as tongue depressors and dental floss.

Let’s review the home laser and light treatments that generally fall into 4 groups: Photorejuvenation, Hair Growth, Hair Removal and Acne Treatment.

Photorejuvenation

  • The newest kinds of home aesthetic lasers are used for skin rejuvenation. The PaloVia Skin Renewing Laser ($499) is the first handheld, fractional, nonablative diode laser that is “cleared” by the FDA for the reduction of fine lines and wrinkles around the eyes. One published study showed one level improvement in the 5 grade wrinkle severity score for fine lines around the eyes after 4 weeks of daily use followed by 12 weeks of twice weekly maintenance treatments. Other home devices are in the pipeline.

Hair-Growth Devices

  • Low-level light therapy (LLLT) devices can stimulate small fine “baby” vellus hairs. In male pattern hair loss, these fine hairs are not actually regrowth as many patients hope, but are in the process of dying. Treatment aims to force those hairs to thicken and regain color.
  • HairMax Laser Comb ($545) is cleared by the FDA for the stimulation of hair growth in male pattern baldness. The comb must be moved over the entire affected area for 8-12 minutes a day to ensure coverage of the entire affected area, with a recommended treatment time of 8-12 minutes a day. A double blinded trial of 110 males with androgenic alopecia (male pattern baldness) demonstrated some increase in mean hair density.
  • LaserCap ($3000), worn under a cap 60 minutes a day, is not yet cleared by the FDA. All hair growth devices must be continued indefinitely for hair growth to be maintained.

Hair-Removal Devices

  • Several devices have been cleared by the FDA home hair removal below the neck. These may be used on light brown to black hair in light to medium skin types. White, gray, red, blond hair does not respond and treatment may produce burns in darker skin types. Tria Laser ($395) is a battery-powered, handheld device with a 1.0 cm (4/10 inch) treatment window. After treatments every 3 weeks for 3 cycles, hair reduction was 60%, 41 %, and 33%, respectively at 1, 6, and 12 months. Treatment time for one armpit is typically 10-20 minutes.
  • Silk’n SensEpil ($499) is a FDA-cleared handheld intense pulsed light device for hair removal on the face and body. After 6 treatments at 2-week intervals the three-month follow-up revealed hair reduction widely varying from 10-72% in one small study. Treatment time for one armpit is 2-3 minutes.

Acne Devices

  • Blue light phototherapy can play a role in the treatment of mild-to-moderate inflammatory acne by destroying the bacteria P.acnes that contributes to acne formation. We use the office strength blue light ClearLight Acne Treatment. Multiple FDA cleared home use devices are available.
  • Both Tanda Clear + ($199) and Tria Clarifying Blue Light ($245) use a 2-3 inch blue light treatment head applied 3 minutes twice a day to each acne prone area, so treatment can be time consuming. A small Tanda Clear + study showed 30% reduction in blackheads and 35% reduction in small red bumps after 4 weeks. No published studies are available for the Tria. The Omnilux Clear-U ($349) uses alternating blue and red light attachments for 20 minutes every 2-3 days. A small study showed 60% reduction of small red bumps after 8 treatments.
  • Other devices use heat to treat individual acne pimples by destroying P acnes bacteria. Zeno Hot Spot ($40) uses a 2.5 min treatment to each pimple every day and 55% of small red bumps were resolved by 5 days. Another spot treatment device, Thermaclear had a shorter treatment time with a hotter pulse. It appears to have been removed from the market after reports of burns.
  • The no’ no! ($180) acne device uses intense pulsed light to a developing blemish. Treatment is two 10 second flashes twice a day to each pimple until resolved. A small study showed that by 4 days, breakouts improved quicker than those that were not treated.

So Do Home Laser and Light Treatments Work?

A number of these home devices can give you some results while incorporating safety features that may make them acceptable treatment options. They are all very significantly less powerful than the office based devices which mean less improvement and more treatment time. Many require bulb or head replacements at intervals. The specific devices reviewed are some of those with some published evidence about safety and results. There are plenty of others with no evidence of safety or results, and none of the devices have anywhere near the amount of studies required of more powerful, office based devices. Don’t overestimate the meaning of FDA’s terminology of “cleared as substantially equivalent” to existing devices. It is not an endorsement of effectiveness. That said it is possible one of these devices will be helpful for you. If you are going to use them, use one that has some published safety and effectiveness studies.

Please note: I am not endorsing any specific device and have no association with any device. We do not sell any of these devices. And I am tired of the word “device.”

1 comment

Posted on October 10, 2015 by Best Skincare Products

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