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Classification of benzoyl peroxide as safe and effective and revision of labeling to drug facts format; topical acne drug products for over-the-counter human use; final rule.

Food and Drug Administration, HHS.
Abstract

We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide. We are also revising labeling for OTC topical acne drug products containing resorcinol, resorcinol monoacetate, salicylic acid and/or sulfur to meet OTC drug labeling content and format requirements in a certain FDA regulation. This final rule is part of our ongoing review of OTC drug products and represents our conclusions on benzoyl peroxide in OTC acne drug products.

LinkedIn Group - Acne Specialists

• An overview of what acne is and why our system is so successful
• All the homecare and treatment protocol used at Face Reality Acne Clinic
• Demonstrations of treatments and extractions
• Bonus CD of all the forms used in consultation and tracking client progress

It incudes all the details that  is needed to successfully get acne clients clear; a protocol that uses only topical products but achieves results far superior than those achieved by prescription drugs and expensive machines.

For more information and to see the first chapter, go to Skincare Professionals - Acne Training DVD

Acne blue light therapy has recently been approved by the FDA as an effective treatment for mild to moderate acne, and is rapidly becoming a more popular treatment choice. But can you really treat acne by simply shining a blue light on your skin?

Common acne, or Acne vulgaris, is caused when sebum produced by the sebaceous glands in the skin gets trapped within the follicle and mixes with cell debris to create a “plug”. This plug causes a backup and creates an environment that the P. acnes bacteria thrive in. The pore then becomes inflamed and may rupture and develop into a pimple, papule, whitehead or cyst depending on the unique physiology of one’s body. The acne blue light is thought to work by obliterating the P. acnes bacteria within the pore thus reducing inflammation and over time clearing the skin of blemishes.

It has long been observed that sunlight has been known to improve acne. Although this is debatable, it was thought to be due to antibacterial effects of the ultraviolet spectrum which cannot be used as a treatment due to the likelihood of skin damage in the long term. It was discovered that some of the visible violet light present in sunlight (in the range 405-420 nm) activates a group of organic compounds in the bacterium called porphyrins which damage and ultimately kill the bacteria by releasing singlet oxygen very much like ozone used in a steam session during an esthetic treatment. This discovery ultimately led to the development of concentrated blue light both for in home use (hand held LED) and for in-patient procedures at a dermatology office.

So is bluelight therapy a laser treatment, a light treatment or chemical treatment?

This is confusing for a lot of people including many estheticians. In many cases it could be considered all three. Bluelight administered in a doctors’s office is performed via intense pulsed light using a laser that activates a chemical. In contrast, hand held bluelights for home use are just light based and do not involve the use of chemicals. The hand held units are composed of neatly arranged light emitting diodes(LEDs). Basically, these diodes are just tiny light bulbs that fit easily into an electrical circuit. But unlike ordinary incandescent bulbs, they don’t burn out or get very warm. They are illuminated solely by the movement of electrons within a material that conducts electricity.

Blue light therapy, also known interchangeably as photodynamic therapy started as an office-based procedure only. Patients with acne would see their dermatologist for treatment. The physician would often apply a sensitizer to the skin called Levulan (amino levulinic acid) for about 30 minutes before the procedure. Then the patient would sit in front of a blue light source, typically a laser that was calibrated for pulsed light for several minutes. This was repeated several times each week for about 6 weeks. The mode of action is as follows: the sensitizing agent penetrated the skin and when activated with the bluelight, it absorbed the energy from the light, killing the bacteria and shrinking the sebaceous glands to effectively decrease oil production.

Does it work?

The initial data had been very encouraging. In October 2002 the American Academy of Dermatology reported the following; “A low intensity blue light source (405 nm to 420 nm) has been studied for the treatment of mild to moderate inflammatory acne. In the study, two 15-minute exposures a week for a period of four weeks produced a 60 percent reduction in acne in 80 percent of patients”.

Interestingly enough blue light without the use of levulinic acid has also been developed. Recent clinical papers suggest that the success rate was a more modest 30-40%. A study published in March 2009 by the Journal of Clinical and Aesthetic Dermatology entitled “the clinical efficacy of self applied bluelight for mild-moderate acne” suggested that overall improvements on average showed a decrease of up to 40% in the number of lesions by day 28 of the treatment.

These numbers sound pretty convincing. So what’s the other side?

First, the cost factor is relatively high. Not unlike many other acne therapies including corrective peels and benzoyl peroxide usage, continuing treatments will be more than likely needed to stay clear. With an average treatment cost of $200-$300 per treatment, an entire course can run you in the upwards of $2000 in constrast to $700 for corrective peels and topical products.

Secondly levulan treatments, now unavailable, can be uncomfortable. The combination of the light and the sensitizing agent causes a stinging sensation. For many, the sensation may be tolerable but some people find it too painful and consequently abandon therapy. Anecdotal research suggests that the pain is akin to laser treatments and the aftermath can leave you swollen, red with generalized sensitivity for a prolonged length of time in comparison to a peel and extraction session. Levulan also sensitizes you to light in general, especially right after treatment. As a result extreme care must be taken not to expose the skin and failure to protect can result in serious burns and permanent pigmentation issues.

Thirdly, many studies and anecdotal evidence suggest that the therapy worked well for those suffering from inflamed acne and abnormally high oil production. It failed to show significant improvement in non-inflamed acne sufferers who had moderate oil production. Up to 40% of all acne sufferers have non-inflamed acne. This means that blue-light therapies basically fail to address these clients at all.

Fourthly, because the sensitizing agent is no longer necessary, you’re not forced to the doctor’s office to get treated. Several companies have developed hand-held blue light devices that you can use yourself. A well made unit can cost an upwards for $300–$400 and in order for it to be effective you must hold it up against the skin for about 10-15 minutes twice a day, every day. Considering that the average person brushes their teeth for less than a minute, 10-15 minutes can seem tedious. Although handhelds are highly recommended in the aid of inflamed acne, the onus is on the user to be diligent.

And finally, despite the statistical claims of the publications from fore mentioned dermatology journals, the authors are very careful to state that the reduction was not statistically significant. Notwithstanding, its initial clinical data, popularity and wide spread availability, on October 2008 Dusa Pharmaceuticals announced that it was no longer developing Levulan for the treatment of acne after the phase II results failed to show statistically significant results.

In conclusion the argument that can be made is that bluelight is not a replacement for other more proven therapies such as peels in combination with benzoyl peroxide or vitamin A products. Rather it could be used as an accessory to these other treatments. In our clinical setting we have observed the following : 50% of our moderate to severely inflamed clients who were given hand held units to use on half the face in addition to our unique topical program showed significant improvement in comparison to their other side that had not been treated with the light. Therefore photodynamic therapy has a reasonable chance of benefitting someone with moderate to severe acne but for best results should be used as an adjunct to managed homecare of appropriate skincare products.

For a proven system of getting clear skin, check out Face Reality Acne Clinic.

Birth control pills are widely used today and prescribed often as a means to control acne. Most pills can have the potential to cause acne and weight gain in those susceptible. Typically the pills are divided up as estrogen or progestin dominant and have varying degrees of androgenic (testosterone like) effects. As a general rule of thumb, pills with the potential for higher androgenic symptoms should be avoided for people prone to acne because they promote breakouts.

As an acne sufferer it is important to speak with your doctor about a selecting a pill that is higher in estrogen and lower in androgen potency.

The most commonly prescribed pills in this category are:

Yasmin

Diane 35(Dianette)

Demulan(Zovia)

Ortho tri cyclen

Nevicon modicon

Ortho evra

Mircette

Desogen(Apri)

It is best to avoid the following pills that are high in androgen activity and low in estrogen.

Loestrin

Estrotrep Fe

Levlen

Alesse

Ovral

Norestrin

Nuvo ring

Depoprovera shot

Only you and your doctor can determine what pill is right for you. The above is just a basic guideline that should be used to initiate a conversation between you and your physician. If you are considering taking birth control pills, it is important to know that they are associated with a high risk of blood clots, weight gain, nausea, mood changes, depression and breast tenderness. Serious side effects include strokes, digestive issues and embolism.

Finally, it is entirely possible to treat acne without going on the pill at all. If you have no underlying health issues that require you to be on birth control and are considering taking birth control pills only to control your acne, please feel free to talk with one of the estheticians to get some additional perspective on how we can help you with the use of topical products and treatments.

For more information about getting clear skin without using prescription drugs please visit Face Reality Acne Clinic.

Research indicates that acne patients, for various reasons, often do not follow the skin care regimen that has been prescribed for them. Studies have also shown that this lack of adherence is one of the main reasons that many acne treatments fail to work.

Clients may not fully understand what they are supposed to do, possibly due to unclear instructions from their skin care provider. Acne treatment products may also lead to unpleasant side effects early on in treatment, if acne clients are not made aware of this; they may use products inconsistently or may just stop using them completely. Also, if the client does not see immediate results from their treatment, they may believe that the skin care regimen is not working. All of these problems – lack of understanding, poor communication by skin care professionals, and misconceptions on the part of the acne patient can all lead to poor adherence and may lead the client to discontinue treatment.

We recently conducted a survey of our clients and found that those who closely followed the skin care regimen we had given them were far more likely to get clear, and were more likely to get clear faster. 92% of clients who followed their regimen completely were clear within 6 months, compared to only 28% of those who did not follow their regimens.

At Face Reality, we tell our clients from day one how important it is to stick to the regimen that we give them. We explain that the products they are using prevent the new acne from forming and that if they skip their homecare that new “microcomedones” get started inside the pore. Those new acne lesions will make their appearance anywhere from 1 to 3 months later. So, you may think that you are getting away with skipping homecare because you don’t see anything right away, but it catches up to you down the road.

We also encourage them to ask us questions at any time if they do not understand what they are supposed to do or if they are having problems with their skin care regimen. This education about regimen adherence is such an important factor for getting clear; that we also regularly check in with our clients to make sure that they are following it correctly. In my experience, a little nagging from us is well worth it if it helps to get our acne clients clear.

Recent research has suggested that many people with complex acne conditions could benefit from an anti Candida diet. Candida is an overgrowth of naturally occurring and symbiotic yeast that coincides with other organism including bacteria in our bodies. Candida albicans is a fungal yeast that may overgrow form over use of antibiotics, steroids, corticosteroids and ibuprofen amongst other strong drugs prescribed for chronic and acute conditions alike.

Bad foods can either cause a fungal problem or help exacerbate it, or both. Good foods, on the other hand, can help cure fungal overgrowth. So what’s good and what’s bad? Candida love a sweet environment. Thus all sugars are bad. Dieticians will often say only fast sugars are bad and slow sugars are good. Thus they will advise against white sugar and white flour and will advocate the use of raw cane sugar and whole-grain products. Sorry if you’re a sweet tooth and carboholic, but all sugars are out if you really want to starve Candida.

This means you will have to wean yourself off:

White sugar;

Cane sugar;

any natural sweetener such as honey, maple syrup, agave nectar, rice syrup, date syrup, corn syrup, wheat syrup, etc.;

White rice;

White flour and white-flour products;

whole-grain yeast bread and other whole-grain products;

Starchy products such as chips, crisps, potatoes, corn, etc.

Commercial fruit juice from a pack;

pasteurized milk products;

Sweet fruits;

Alcohol;

Coffee and black tea

Mushrooms

Beans and legumes

Vinegar

Soy based foods such as tofu, tempeh, soy meats and soy sauce.

Nuts especially cashews and peanuts

Foods that contain msg as in “natural flavours”, autolyzed yeast extract, soy extract, soy sauce

Processed and pasteurized cheeses.

Simply put, the anti-Candida diet is about avoiding all sugars and foods that are very high in fat and fungi.

Instead the following foods are recommended on a long term basis to encourage clear skin

Only stevia as a sweetener;

Sourdough or sprouted grain bread;

Daily salads made up of organic green leafy vegetables, sprouts, and carrots with a dressing of freshly squeezed lemon juice and omega-3 rich oils, such as flaxseed, olive, walnut, sesame and coconut oil;

Lightly cooked or steamed food;

Freshly squeezed or blended fruit juices including the pulp and seeds and even some of the rinds of only sour and bitter organically grown fruits, such as lemons, limes, pomegranates, berries, grapefruit and Braeburn, Roman Beauty and Granny Smith apples;

Organic green tea;

Organic chicory coffee.

Supplements and herbs and spices

Supplements and herbs and spices to take before, during and after the Candida diet, in no particular order:

Goji berries

Vitamin-B complex

MSM

Wheat grass juice and/or barley greens

Chlorella

Spirulina

Alpha Lipoic Acid

High quality probiotic supplement with acidophilus, bifidus etc.

Zinc monomethionine

Pau d’ arco tea

Grapefruit seed extract

Raw pure virgin coconut oil

High quality fish oil (liquid or capsules)

Flax seed oil (liquid only)

Turmeric

Ginger

Cayenne Pepper

Mint

Garlic

L-Ascorbic Acid

Highly recommended Brands: Candi-gone, Dr. Ohhira’s probiotics, Udo’s choice Oil Blend, Carlson’s fish oil, Flora Now Critical care probiotics, Just Barley- All available at Whole Foods.

Zinc Monomethione available at Face Reality.

Please remember to inform and consult your physician about going on any extended or restrictive diet such as this one. Please use common sense and do not eat foods that you are allergic or sensitive to.

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