#acne clinical research protocol writing

[dermatology-cro]

[biofunmy]

Can One LED Light Give You Perfect Skin?

The MMSphere, a ring of LED lights, casts a red glow over my face. It sits adjacent to my laptop so that as I write, research and procrastinate, I can simultaneously calm a fiery constellation of acne on my left cheek.

Red light’s anti-inflammatory and collagen-building effects on the skin are well documented. But this hands-free device, designed by Ellen Marmur, a dermatologist in New York, has settings for blue, green, amber and purple light too.

“It has just enough variety that people stay excited to use it,” Dr. Marmur said.

I, too, begin cocktailing. I bathe my face in blue light to kill acne bacteria while watching reruns, and immediately follow up with a FaceTime call to my mother, my face lit up in a bright green light to fight hyperpigmentation.

Skin care efficacy lives and dies by patient compliance. Most at-home LED skin care devices are small and hand-held, requiring time set aside to treat the entire face. People eventually stop using them.

Even with persistent acne as a motivator, I’ve always had trouble following LED protocols. The MMSphere ($495) is a big deal for me because it harnesses a powerful fix-everything-while-doing-nothing ease that makes it almost addictive. You actually want to use it.

“It makes people feel good, like they’re taking care of themselves,” Dr. Marmur said. “You can treat your skin while doing other things, so it’s easier to form the habit of doing it every day.”

Because, really, if we’re just sitting around — talking, eating, working — shouldn’t we be fixing our skin, too?

So how does LED work?

First, LED therapy is not the same as a laser treatment, which creates controlled damage to the skin to promote healing. The easiest way to understand the light-as-skin-care concept is to think of skin-friendly visible light as ultraviolet light’s benevolent counterpart.

In a process called photobiomodulation, light alters biological material; for example, UV rays from the sun change our skin in ways that can catalyze cancer and aging.

But some wavelengths of visible light alter our skin for the better, and light-emitting diodes (LED) are a source that delivers that energy.

Jared Jagdeo is an associate professor of dermatology and director of the Center for Phototherapy, SUNY Downstate Health Science University, where he studies LED therapy.

“You can alter the skin through photo-damaging with lasers, or photobiomodulation, which is a much more gentle way of changing the way the skin functions,” Dr. Jagdeo said. Red and blue light are the heavy hitters. He explained why red light in particular works so well.

“There’s a specific receptor in the mitochondria of the skin cells that red light specifically acts upon,” he said. “And that’s why red light is an ideal wavelength for changing the way the skin functions.”

Red light penetrates the skin deeper than other visible light and stimulates the mitochondria, which has an anti-inflammatory and rejuvenating effect. Collagen is built in the dermis, the skin is calmed, and wrinkles eventually fade.

Blue light doesn’t penetrate the skin as deeply but zaps acne-causing bacteria on the surface. The science on green light isn’t as solid, but in theory, it targets melanocytes, discouraging excess melanin production.

Rigorous independent studies have yet to be conducted, but Dr. Marmur did a very small clinical trial on green light for the MMSphere in which subjects self-reported a 32 percent decrease in “brown spots” after a week of green light treatment.

And what about those other colors?

The MMSphere emits five different colors of light and shuts off after a 20-minute session. Its violet is a combination of red and blue light, so you get both colors in one treatment.

MMSphere’s last color, amber, doesn’t have much of a skin care benefit, but it may be a mood booster, and is sometimes used to treat seasonal affective disorder.

Is all of this light O.K. for my eyes?

Eye safety is a valid concern, particularly because earlier this year Neutrogena recalled its LED mask over fears that it could cause eye injuries.

Brian S. Biesman, an assistant clinical professor of ophthalmology, dermatology and ENT at Vanderbilt University Medical Center in Nashville, said that most home devices aren’t powerful enough damage the eyes. The MMSphere comes with opaque goggles, but, Dr. Biesman said, the device is low energy, so it should be safe to use without them.

“Just normal blinking and eye movements should be sufficient to protect the eyes,” he said. “But never stare at a bright light source.”

How do I know if my LED light is working?

This is where things get more complicated. Even though LED devices are everywhere, the science to establish standards for at-home use is nascent. Buy only devices cleared by the Food and Drug Administration, but think of that clearance as a testament to their safety, not their efficacy.

“As far as the F.D.A. is concerned, if I use CO2 laser resurfacing, it better work because of the amount of risk involved,” said Suzanne Kilmer, a clinical professor of dermatology at the UC Davis School of Medicine in Sacramento and director of the Laser and Skin Surgery Medical Group.

“Compare that to a home device,” Dr. Kilmer said. If it doesn’t kill you, blind you or make things much worse, it’s probably going to get approved. So it’s actually more incumbent upon the people selling home devices to show efficacy. You have to trust the people who are selling them.”

“LED is real, but it’s probably not optimized yet,” Dr. Kilmer said.

Many factors determine the amount of light your skin needs and receives: the strength of the light, the distance from source to skin, how long the light is used, and your skin color.

“Some of these lights on the market are very weak, and they may not have enough energy output to actually have a biological effect,” Dr. Jagdeo said. “Imagine a glow stick. It produces a color. But you could shine it on your face all day, and it’s not going to change the way your skin works.”

Furthermore, the medical community has yet to establish standard doses for treating conditions like hyperpigmentation and acne at home. Dr. Marmur based her MMSphere dosing on Blu-U, an in-office blue light that is commonly used as an alternative therapy for precancerous lesions.

“Consistent Sphere treatment for seven weeks will equal the energy given in the office with the Blu-U,” she said.

Another device, the Dr. Dennis Gross DRx SpectraLite FaceWare Pro, $435, emits red and blue light in a mask format, and each session is only three minutes. The mask’s LEDs are in contact with the skin, which may be a more effective treatment. Dr. Jagdeo said that you lose some energy on the way from device to skin, a potential downside of the MMSphere design.

“This is a tremendously undertapped area in medicine,” he said. “But LED light therapy is going to revolutionize the way home medical treatment is delivered for skin care over the next 10 to 15 years.”

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[ghaw2007]

10 Manuka Honey Benefits

10 Manuka Honey Benefits

1. Helps with SIBO, Low Stomach Acid, Acid Reflux

Small intestine bacterial overgrowth (SIBO), low stomach acid and acid reflux go hand in hand. Because of Manuka honey’s known natural antibiotic qualities, it is a great medicine for any bacteria-related disorder.

In fact, in a recent study, one dangerous bacteria related to all three conditions, Clostridium difficult, was found to be quite susceptible to Manuka honey’s bactericidal effects. (2) So taking Manuka honey is very beneficial at reducing acid reflux and balancing your digestive system to heal stomach and intestinal imbalances.

2. May Help Treat Acne and Eczema

The Internet is filled with patient testimonials that Manuka honey works marvelously for acne and eczema patients. At this time there are few clinical trials to support these claims, but taking into account its proven antimicrobial and healing properties, it is believed honey can help with these skin conditions. (3)

One recent review of clinical and cellular studies on Manuka honey’s effects in treating atopic dermatitis found that it “is potentially effective in the treatment of AD lesions based on both clinical and cellular studies through different mechanisms. This needs to be confirmed by randomized and controlled clinical trials.” (4)

Most people claim that applying honey on affected areas for a few minutes and then washing off with gentle soap and water usually does the trick. Repeat this every day or every other day for the best results.

3. Combats Staph Infections (MRSA)

You’ve probably heard of the superbug that has plagued hospitals over the several years, methicillin-resistant Staphylococcus aureus (MRSA). Antibiotic overuse and drug ineffectiveness have caused certain strains of Staph to become virtually indefensible using typical hospital and nursing home medical protocols. Spreading so rapidly, most people affected by MRSA end up getting so infected that they require invasive procedures or devices, such as surgeries, artificial joints or intervenes tubing, to save their lives against these dangerous superbugs — as antibiotics often don’t work. (5)

However, U.K. researchers from Cardiff Metropolitan University have offered us some natural hope. They discovered that Manuka honey down-regulates the most potent genes of the MRSA bacteria. Some scientists now suggest that regular topical use on cuts and infections (especially in the hospital and nursing home setting) may keep MRSA naturally at bay. (6)

4. Treats Burns, Wounds and Ulcers

According to research published in the Jundishapur Journal of Natural Pharmaceutical Products, “The use of honey leads to improved wound healing in acute cases, pain relief in burn patients and decreased inflammatory response in such patients.” (7) Moreover, because of its rich antioxidant, antibacterial and anti-inflammatory characteristics, Manuka honey has been shown to prevent infection in rats with ulcers. (8) It has also been used quite effectively as a wound dressing to promote rapid, improved healing.

5. Prevents Tooth Decay and Gingivitis

Several studies have come out describing how Manuka honey can help treat and prevent gingivitis and periodontal disease. Due to its superior antimicrobial activity, researchers from the School of Dentistry at the University of Otago in New Zealand discovered that chewing or sucking on a Manuka honey product not only caused a 35 percent decrease in plaque, but it led to a 35 percent reduction in bleeding sites in people suffering from gingivitis. (9) Also calcium, zinc and phosphorus are all important nutrients for healing teeth.

6. Aids IBS and IBD Treatment

When evaluating the effect that Manuka honey has on experimentally induced inflammatory bowel disease in rats, researchers from Chandigarh Postgraduate Institute of Medical Education and Research discovered several astounding findings: (10)

Manuka honey at different doses provided protection against TNBS-induced colonic damage.

All the treated groups showed reduced colonic inflammation, and all the biochemical parameters were significantly reduced compared with the control in the Manuka honey treated groups.

Manuka honey at different doses restored lipid peroxidation as well as improved antioxidant parameters. Morphological and histological scores were significantly reduced in the low dose Manuka honey treated group.

In the inflammatory model of colitis, oral administration of Manuka honey significantly reduced the colonic inflammation.

So Manuka honey not only treated intestinal inflammation and pain, but also repaired free radical damage and protected against further damage.

7. Improves Sore Throats and Immunity

In 2007, data published in the Journal of Leukocyte Biology suggested that, “A 5.8-kDa component of Manuka honey stimulates immune cells via TLR4.” (11) This is interesting because previous studies have indicated that honey stimulates cytokine production from human monocytes.

Coupling with this 2011 research showing how Manuka stops the growth of sore throat-causing Strep bacteria, it is no wonder that so many people benefit almost instantly from taking a spoonful of honey when they don’t feel well. (12) Recently it has even been approved by the National Cancer Institute to be used to treat inflammation in the throat from chemotherapy.

8. Helps Allergies

A study conducted by the South Karelia Allergy and Environment Institute in Findland examining the effects of honey and birch pollen on allergies that had remarkable results. The participants were given regular honey, honey with birch pollen added to it and some used only their allergy medicines as a control group. The results were impressive:

…patients reported a 60% lower total symptom score, twice as many asymptomatic days, and 70% fewer days with severe symptoms, and they used 50% less antihistamines compared to the control group.

The researchers also found that there was very little difference between the birch pollen honey users and the regular honey users. So, taking Manuka honey on a regular basis may really help your seasonal allergies and lessen your need for medications. (13)

9. Beauty Treatment and Health Booster

Taken daily, Manuka honey has an elixir effect that boosts energy and enhances your quality of life. Because of its nutrient-dense profile, it boosts vitality, youthful energy, and has been known to improve skin tone and texture.

Use it in a homemade face wash to exfoliate and fight free radicals in the skin. Use it in your shampoo or a hair mask to boost the shine of your hair. One of my favorite uses is in a detox drink, to get the most benefits inside and out!

10. Improves Sleep

Manuka Honey helps to promote restful deep sleep. It slowly releases the glycogen needed for essential bodily functions during sleep. Adding honey to milk at bedtime helps the body release melatonin into the brain, which is necessary for deep sleep. (14)

There are many health disorders associated with poor sleep, such as heart disease, type II diabetes, stroke and arthritis. Since honey is proven to aid in quality sleep, it also helps lower the risk of these and many other health problems.

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[sherristockman]

The Many Benefits of NAC — One of the Most Important Supplements You’ve Likely Never Heard Of Dr. Mercola By Dr. Mercola N-acetylcysteine (NAC) — a precursor which is needed for glutathione biosynthesis — is an incredibly useful supplement that few people have even heard of. Many of its benefits relate back to the fact that it helps boost production of glutathione, an important antioxidant your body produces naturally that helps reduce free radical damage and plays a role in the detoxification of heavy metals and other harmful substances. NAC is both safe and inexpensive, and has been commercially available for a long time. It's also generally well-tolerated and has no known serious side effects. Considering its wide array of health benefits, it's a supplement worthy of consideration for many. As noted in a recent medical review of NAC's many clinical uses, it is a:1 "… potential treatment option for diseases characterized by the generation of free oxygen radicals. Studies have shown no maternal or fetal harmful effects of NAC treatment … NAC prevents apoptosis [editor's note: programmed cell death] and oxygen related genotoxicity in endothelial cells by increasing intracellular levels of glutathione and decreasing mitochondrial membrane depolarization." NAC Helps Counter Toxic Effects of Alcohol NAC supplementation can also help "pre-tox" your body when taken before alcohol, thereby minimizing the damage associated with alcohol consumption — a tidbit that may be useful to know in light of the approaching holidays. NAC is a form of the amino acid cysteine, which in addition to increasing glutathione also reduces acetaldehyde toxicity that causes many hangover symptoms.2 Taking NAC (at least 200 milligrams) 30 minutes before you drink can help lessen the alcohol's toxic effects. NAC is thought to work even better when combined with vitamin B1 (thiamine).3 Vitamin B6 may also help to lessen hangover symptoms. Since alcohol depletes B vitamins, and B vitamins are required to help eliminate alcohol from your body, a B vitamin supplement taken beforehand, as well as the next day, can be helpful. All of that said, it's important to realize that this protocol will not reduce your susceptibility to alcohol poisoning or other acute adverse events associated with binge drinking, so please use common sense and drink responsibly. NAC Is a Potent Antidote to Acetaminophen Toxicity NAC is also used in medicine as an antidote for acetaminophen toxicity. Like alcohol, one way that acetaminophen causes liver damage is by depleting glutathione. If you keep your glutathione levels up, the damage from the acetaminophen may be largely preventable. This is why anyone who overdoses on Tylenol receives large doses of NAC in the emergency room — to increase glutathione. Mortality due to acetaminophen toxicity has actually been shown to be virtually eliminated when NAC is promptly administered in cases of acetaminophen overdose. While I generally do not recommend using acetaminophen-containing drugs for minor aches and pains, they are sometimes necessary to temporarily suppress severe pain, such as post-surgical pain. So, if you ever use acetaminophen I strongly recommend taking it along with NAC. And, if you have children and keep acetaminophen in your home, I strongly recommend keeping a bottle of NAC as well in case of accidental overdose. NAC therapy should be initiated within eight hours of an acute overdose for best results. If you suspect an overdose has occurred, seek medical help right away. If this isn't an option, the World Health Organization (WHO) recommends the following protocol:4 "Oral administration is the preferred route for NAC therapy unless contraindications exist (e.g aspiration, persistent vomiting). The usual recommended loading dose is 140 mg/kg followed in 4 hours by a maintenance dose of 70 mg/kg orally given every 4 hours. This dosing is commonly recommended to be continued for 72 hours; however more recent clinical experience supports tailoring the duration of therapy to the patient's clinical condition." NAC Offers Important Liver Support The most common use of NAC is for liver support in general. A 2010 study5 — in which it was noted that the antioxidant resveratrol has been found to enhance replication of the hepatitis C virus and hence is not a suitable supplement for those with hepatitis C — suggests NAC may be a better alternative for this and other chronic liver diseases. "Consistently, we found that [NAC] modulates the expression of iNOS [editor's note: iNOS is an inducible and calcium-dependent isoform of the enzyme nitric oxide synthase or NOS, which helps synthesize nitric oxide] in human hepatocytes stimulated by proinflammatory cytokines," the authors write. "The effect occurs by blocking the activation of the iNOS promoter, and is associated with modulation of NF-κB activity, a central transcription factor for induction of iNOS expression. The biological phenomenon might well be the basis of the therapeutic effects of NAC on chronic liver diseases different from those caused by acetaminophen intoxication." Other Health Benefits of NAC Aside from its hepatoprotective effects, research suggests NAC may also help:6,7,8 Prevent chronic obstructive pulmonary disease exacerbation Improve muscle performance Prevent contrast-induced kidney damage during imaging procedures Protect against Alzheimer's disease when taken in combination with lipoic acid Attenuate influenza when started before infection Reduce symptoms associated with ulcerative colitis Treat pulmonary fibrosis Prevent asthma Improve male fertility by improving sperm quality, and treat infertility in female patients with clomiphene-resistant polycystic ovary syndrome. It's also been shown to reduce risk of premature birth and miscarriage Treat certain forms of cancer and protect against toxicity of radiotherapy; DNA damage has been shown to be "completely blocked" by NAC. Beware that some of the evidence suggests NAC may not work well with some forms of chemotherapy, so do not use as a cancer treatment adjunct without consulting your doctor Decrease frequency, duration and symptoms in patients with chronic bronchitis Improve symptoms associated with Parkinson's disease and ALS Treat HIV infection Reduce tissue inflammation Reduce your risk of insulin resistance Reduce symptoms associated with schizophrenia Prevent addictive behaviors such as binge eating, drug addiction (especially cocaine addiction) and other compulsive behaviors such as nail biting by normalizing the neurotransmitter glutamate Prevent depression, bipolar disorder and obsessive compulsive disorder, and improve daily function in those with these disorders Improve intestinal barrier function, reducing your risk of leaky gut Enhancing the regeneration of bone; speeding up bone mineralization Improve sleep and reduce snoring in those with obstructive sleep apnea Treatment of polycystic ovary syndrome Increase survival rate in patients with chronic heart failure Increase survival rate in patients who have had a heart attack Reduce your risk of heart disease Aid in recovery from brain injury Treat Helicobacter pylori infection when used as an adjunct to other therapy Protect against gentamicin-induced hearing loss in patients on renal dialysis NAC Offers Hope for Patients With Parkinson's and Other Neurodegenerative Conditions As you can see, the list of NAC's potential uses is quite long; there's even evidence it may be an effective remedy against acne, decreasing acne outbreaks by about half.9 Some of its most promising uses is as a neuroprotectant. Scientists are currently investigating it as a treatment for Parkinson's disease — a disorder that has been linked to glutathione deficiency in the substantia nigra, a region that houses dopamine neurons.10 Research looking at autopsied brains suggests Parkinson's patients have barely detectable levels of glutathione in this brain region. This deficiency is not restricted to Parkinson's, however. Subsequent studies have found glutathione deficiency in the substantia nigra is common in a number of other neurodegenerative conditions as well, including progressive supranuclear palsy, multiple system atrophy and Alzheimer's disease.11 As noted in a recent article by Science of Parkinson's:12 "Researchers have subsequently found that decreased levels of glutathione does not directly result in dopamine cell loss … but it does make the cells more vulnerable to damaging agents (such as neurotoxins … ) This has [led] investigators to ask whether administering glutathione to people with Parkinson's disease would slow [down] the condition." In one small-scale clinical trial,13 600 milligrams (mg) of intravenous glutathione was administered twice a day for 30 days, after which the patients were monitored for up to four months. All experienced significant improvement, with an average decline in disability of 42 percent. The effects lasted for two to four months after the treatment ended. The remarkable effects of the treatment are demonstrated in the following video. Other studies have confirmed the usefulness of NAC in the treatment of Parkinson's. Several are discussed on Science of Parkinson's, so for more information, please see that original article.14 As just one example, a randomized study15,16 on 23 patients found a combination of 600 mg of oral NAC twice a day plus a weekly IV infusion of NAC at 50 mg per kilogram of body weight, had a very consistent, neuroprotective effect, improving patients' mental and physical abilities. Brain imaging also confirmed beneficial changes were in fact occurring in the brain. PTSD, Depression and Treatment of Addiction Another area where NAC shows particular promise is in the treatment of mental health disorders, including post-traumatic stress disorder (PTSD), depression and substance use disorders. In one recent study,17 PTSD symptoms in war veterans decreased by 46 percent, substance use cravings by 81 percent, and depression by 48 percent after NAC treatment. Here, patients took 2,400 mg of NAC a day for eight weeks. As a group, the veterans no longer met diagnostic criteria for PTSD at the end of their treatment. This, lead author Sudie Back, Ph.D., said, "are some of the best outcomes we have seen in the literature for a medication." As reported by Medical University of South Carolina (MUSC):18 "Currently, there are no well-explored pharmacological treatments for patients with co-occurring PTSD and substance use disorder. Although selective serotonin reuptake inhibitors, a class of drugs used as antidepressants, have been approved by the FDA for treatment of PTSD, pharmacological treatments for co-occurring conditions haven't been as effective as some hoped for. Groundbreaking basic science research by [Back and Peter Kalivas, Ph.D., chairman of the department of neuroscience at MUSC] has shown that levels of glutamate transporters in the brain are decreased in substance use disorders, and NAC can help restore those levels and guard against relapse in animal models of substance use disorder. Because evidence suggests that substance use disorder and PTSD share overlapping neurobiological pathways, Sudie Back … hypothesized that NAC treatment with therapy would be a novel approach to treating the co-occurring conditions. Back is a professor in the Department of Psychiatry and Behavioral Sciences at MUSC and a staff psychologist at the Ralph H. Johnson VA Medical Center." In studies19 looking at NAC for bipolar depression, individuals taking 1 gram of NAC twice a day for two months reduced their depression score by eight points and reported improvement in functioning and quality of life. It's also been shown to help those with treatment resistant depression and, to a lesser degree, major depressive disorder. Do beware, however, that NAC may interact with certain antidepressants if you take them together, making the antidepressant more potent. As a result, you need to work with your doctor as you may need to reduce the dose of your antidepressant medication if you take it concomitant with NAC. NAC May Improve Fertility in Both Men and Women The last area I will home in on here is fertility, as both male and female infertility are on the rise. A number of studies20 have demonstrated the benefits of NAC for fertility in both men and women. As noted above, NAC has been shown to improve sperm quality in men. It's also been shown to improve the ovulation rate in women by 52 percent.21 In this study, women took 1,200 mg per day of oral NAC for five days, starting on the third day of their menstrual cycle. Endometrial thickness also significantly improved. Other research shows NAC helps improve the quality of a woman's eggs22 — a factor that can improve your chances of not only getting pregnant naturally, but also improve your odds of successful IVF treatment. It also lowers your risk of miscarriage, and increases the pregnancy rate in women who have had recurrent miscarriages.23 Endometriosis, which is a common cause for female infertility, is also improved by NAC supplementation.24 In one Italian study,25 women who took 600 mg of NAC three times a day for three consecutive days per week, for three months, saw such significant improvement that half of the treatment group — 24 out of 47 — were able to cancel their surgeries. Eight of the 47 women receiving NAC had complete remission of cysts. In comparison, only one of the 45 women in the control group (which received a placebo) was able to cancel her surgery and only four had remission of cysts. General Dosing and Safety Guidelines NAC is widely available as an oral dietary supplement and is relatively inexpensive. Unfortunately, it's rather poorly absorbed when taken orally. According to some studies,26,27 oral bioavailability may range between 4 and 10 percent. Its half-life is also in the neighborhood of two hours, which is why most study subjects take it two or three times a day. Due to its poor bioavailability, the recommended dosage can go as high as 1,800 mg per day. No maximum safe dose has yet been determined, but as a general rule, it's well-tolerated, although some do experience gastrointestinal side effects such as nausea, diarrhea or constipation. Should this occur, reduce your dosage. It's also best taken in combination with food, to reduce the likelihood of gastrointestinal effects. Also keep in mind that since NAC boosts glutathione, which is a powerful detox agent, you may experience debilitating detox symptoms if you start with too high a dose. To avoid this, start low, with say 400 to 600 mg once a day, and work your way up. Also, if you are currently taking an antidepressant or undergoing cancer treatment, be sure to discuss the use of NAC with your physician, as it may interact with some antidepressants and chemotherapy.