FDA Approved Blue Light Therapy for Acne

The FDA approved blue light therapy for acne in August 2002.  The first approved system of treatment, ClearLight, is available through dermatologists. Patients are exposed to a blue light source for 15 minutes twice per week for 4 weeks. Each treatment costs between $50 and $150 per session, making a full course of treatment an average of $800. Light therapy for acne is considered "cosmetic" and is therefore not covered by insurance.

Blue-light therapy. The FDA approved narrow-band, high-intensity blue-light therapy for treating acne. Now widely advertised, this is probably the best-known light therapy for acne treatment. Blue light works by killing the bacteria, P. acnes, and is being used to treat inflammatory acne vulgaris that has not responded to other acne therapies. The blue-light products of today do not contain ultraviolet (UV) light, which was a staple of former light therapy used to treat acne. UV light can damage skin and is no longer used to treat acne.

P. acnes, the bacterial responsible for aggravating acne inflammation, pumps out tiny molecules called porphyrins. When those porphyrin are exposed to certain wavelengths of light (blue), they produce free radicals that kill the bacteria that causes inflammatory acne.

Downside: free radicals cause damage to skin cells and speed skin aging. Over a period of time the volume of free radicals acts just like continual sun exposure, damaging skin components such as collagen and causing the skin to sag and wrinkle.

Additionally, the healing process of acne infections involves thousands and thousands of chemical processes.  These chemical processes produce more free radicals as a natural by-product and add to the volume of free radical damage (aging). 

Did you know that your skin produces hydrogen peroxide to fight each acne infection and this may continue for weeks, until the infection is resolved? The skin has a supply of antioxidants that reduce the volume of free radicals and their damage.  It is believed that moderate to severe acne literally depletes the skin's level of antioxidants, leaving it nearly defenseless against free radicals that are created by normal skin functions.

Control of acne is not only important to the appearance of the skin today, it is an important strategy to prevent the premature aging of the skin.  If skin damage has already become a problem,  you should achieve control of acne quickly and once this is accomplished, continue treating your skin with BIOSKINCARE to effectively rejuvenate your skin.

BIOSKINCARE provides antioxidants that fight free radicals. While moderate to severe acne will cause the skin to age quickly, the use of blue light will significantly increase this speed.

Clinical Studies for Blue Light Therapy

The U.S. Food and Drug Administration (FDA) classifies laser and light therapies as procedure-oriented, so the stringent, long-term studies necessary for approval of drugs is not required. As such, more comparative studies are needed to determine long-term effects and to perfect these technologies. However, data from recent studies indicates that laser and light therapies show much promise in treating acne. Here’s what is known:

Patients receive blue-light therapy in increments. Generally, eight sessions are given over a four-week period, and each session lasts about 15 minutes. Side effects tend to be mild and include temporary pigment changes, swelling of the treated areas, and dryness.  As the results from the following studies show, many patients — but not all — see noticeable improvement with about 55% clearance:

• 31 patients with symmetrical (same on both sides) facial acne received blue-light treatment on 1 side of their faces. Blue-light therapy was given twice a week for four consecutive weeks. The other side of each patient’s face did not receive any treatment so that researchers could judge the effectiveness of the blue-light therapy. The researchers concluded that blue-light therapy is an effective acne treatment unless the patient has nodulocystic acne lesions, which tend to worsen when treated with blue light. (Taiwan 1)
   

• 25 patients with inflammatory acne on their faces had half of their face treated with blue-light therapy (8 sessions over 4 weeks) and the other half with clindamycin (a topical antimicrobial shown successful in treating acne). Patients were instructed to apply the clindamycin twice a day for four weeks. After four weeks, the clindamycin side showed a 22.25% improvement, and the side treated with blue light improved by 39%. However, after eight weeks and without further treatment, the side treated with clindamycin was better able to maintain results. (United States 2)
   

• 10, 13, and 25 patients were enrolled in three separate studies designed to learn more about the effects of blue-light therapy on papulo-pustular (inflammatory) acne. In all three studies, more than 80% of the patients treated with blue-light therapy responded to the treatment. The patients who responded saw a 59% to 67% reduction in inflammatory acne lesions. (Israel 3)
   

• 30 patients with mild to moderate acne were treated twice a week with blue-light therapy for up to five weeks. After five weeks, acne lesions decreased by 64%. However, not all patients saw improvement; 20% remained unchanged or experienced a worsening of their acne. (Japan 4)

As you can see, the number of patients involved in these studies is small. Clinical trials conducted to test new drugs generally must enroll hundreds to thousands of participants before submitting the data to the FDA for consideration. With such small numbers, statistically valid conclusions cannot be drawn. Research also is needed to learn the long-term effects. At present, blue-light therapy appears to improve acne vulgaris in some individuals. This therapy appears most effective for inflammatory acne lesions and may not be suitable for patients with nodulocystic acne.

Pulsed light and heat energy (LHE) therapy. This treatment combines pulses of light and heat, which researchers believe target two causes of acne.

It is known that LHE destroys P. acnes, the acne-causing bacteria. LHE also may decrease sebum (oily substance) production by shrinking the sebaceous glands. A system that combines pulses of green light and heat has been approved by the FDA for treating mild to moderate acne. Here’s what a recent study showed:

• 19 patients with mild to moderate acne received two LHE treatments per week for four weeks. At the end of eight treatments, researchers saw significant clearance in both inflammatory and non-inflammatory lesions. Further improvement was seen one month after the last treatment. The most significant reduction in lesions was observed two months after the last treatment was given. Researchers concluded that LHE technology is effective and safe for treating acne vulgaris. (Israel 5)

ALA + light therapy. Studies are investigating the effectiveness of this therapy in treating acne. Patients receiving this treatment undergo a two-step process. First, a solution of 5-aminolevulinic acid (ALA) is applied to the skin to be treated. ALA is a medication that increases sensitivity to light. When used to treat acne, the ALA is kept on the skin for a period of time ranging from 15 to 60 minutes. The length of time depends on the severity of the acne. Step two involves removing the ALA and treating the skin with light therapy. Since ALA makes the skin more light sensitive, patients are instructed to use sun protection for 48 hours after treatment.

Findings from research studies indicate that treatment with blue or red light after the application of ALA is effective. However, as the following shows, red light may produce some undesirable side effects:

• 10 patients who received multiple treatments of ALA + red-light therapy on their backs had a statistically significant reduction in inflammatory acne lesions. However, the side effects, such as temporary darkening of the skin and development of folliculitis (an inflammation of hair follicles that resembles acne), limit recommendation of this treatment. (United States 6)

A recent study that looked at using ALA followed by blue light concludes that this therapy may be suitable for acne treatment. (Israel 7)

Diode laser. A few studies have looked at the possibility of treating acne with the 1450-nm diode laser. One study found that the 1450-nm diode laser effectively treats inflammatory acne on the back. Recently, a study looked at using this laser to treat facial acne:

• 19 patients with inflammatory acne on their face were treated with the 1450-nm diode laser to evaluate the safety and effectiveness of using this laser to treat facial acne. Every patient saw a significant reduction in acne lesions. After one treatment, lesion counts decreased 37%. A 58% decrease was seen after two treatments, and lesion counts decreased by 83% with three treatments. The researchers found that the pain associated with diode-laser treatment is well tolerated with a topical anesthetic. Side effects in this study were limited to temporary redness and swelling at the treatment sites. (United States 8)

Pulsed dye laser. Two studies looked at treating facial acne with the pulsed dye laser. Results were inconsistent.

• 41 patients with mild to moderate inflammatory acne on their faces were recruited. These patients were randomly selected to receive either one treatment with a pulsed dye laser or a treatment that they thought was the investigational therapy (placebo). After 12 weeks, the patients treated with the pulsed dye laser had a statistically significant reduction in acne lesions — 53% for total lesions and 49% for inflammatory lesions. A significant reduction in lesions was not observed in the patients treated with the placebo. Researchers concluded that the pulsed dye laser improves inflammatory facial acne after just one treatment without serious side effects and that future study is needed. (United Kingdom 9)
   

• 40 patients aged 13 and older who had facial acne received either one or two pulsed dye laser treatments to one-half of the face. The other half of the face was left untreated. After 12 weeks, researchers found no significant difference between the treated and untreated sides. This study concluded that treatment with the pulsed dye laser did not significantly improve facial acne and more research should be conducted before this laser therapy is recommended for acne. (United States 10)

Still Not Routinely Prescribed
While the results from these studies are promising, the use of lasers and light therapies to treat acne is still in the investigational stage and may not be the first choice for treating acne. If you are considering a laser or light therapy to treat acne, you should know the following:

More research is needed. Controlled studies with large number of patients are needed to:

• Know which therapy is best for which patient. To date, it appears that laser and light therapies are more effective on adults. However, the profile of a good candidate for each type of treatment still needs to be developed.

• Evaluate the effectiveness of each therapy. To date, consistent results have not been obtained in the research studies.

• Determine if there are long-term side effects.

• Find out if the results last after the treatments are discontinued.

Studies that can provide long-term data are in the planning stages.

Many patients require multi-targeted approach. Acne develops when one or more of the following occurs: excess sebum production, rapid production of P. acnes, skin cells shed too quickly, and release of inflammatory substances. For treatment to work it must interfere with what is causing the acne.

Since some of the laser and light therapies target only one cause, a patient’s acne may not resolve. For example, blue-light therapy targets only P. acnes, so acne will resolve only when this is the sole cause. If other factors are present, blue-light therapy will not clear the acne.

Insurance does not cover these therapies. Most insurance plans classify the light and laser treatments used to treat acne as “emerging technologies.” Insurance generally does not cover treatments classified as “emerging technologies.” A patient who opts for the FDA-approved blue-light therapy can expect to pay about $100 to $200 per treatment session. Since eight sessions are typically needed, the average out-of-pocket cost is $800 to $1,600 over the recommended four-week period.

With time, research, and experience, laser and light therapies may eventually be light years ahead of traditional acne therapies. Studies indicate that these treatments offer a promising non-invasive alternative. Until more is known, laser and light therapies offer an alternative for individuals whose acne has not responded to traditional acne therapies.

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