May 9th, 2013, by David Pascoe | acne treatments
Seems like a solid result, showing that in patients with `slipped discs’ (prolapsed is a better term) can benefit from antibiotic therapy to eliminate Propionibacterium acnes.
This bacteria is known to play a role in acne and is now believed to have a role in the inflammation of chronic lower back pain.
Participants in these trials were treated with Bioclavid for 100 days. Bioclavid contains Amoxicillin and clavulanic acid.
Whilst we know that P. acnes does not play a major role in rosacea, this is still an interesting result – confirming that there is still a lot about the role of bacteria in our bodies that we are yet to discover.
Antibiotics could cure 40% of chronic back pain patients
Ian Sample, science correspondent
guardian.co.uk, Tuesday 7 May 2013 09.30 BST
Scientists hail medical breakthrough by which half a million UK sufferers could avoid major surgery and take antibiotics instead
Up to 40% of patients with chronic back pain could be cured with a course of antibiotics rather than surgery, in a medical breakthrough that one spinal surgeon says is worthy of a Nobel prize.
Surgeons in the UK and elsewhere are reviewing how they treat patients with chronic back pain after scientists discovered that many of the worst cases were due to bacterial infections.
The shock finding means that scores of patients with unrelenting lower back pain will no longer face major operations but can instead be cured with courses of antibiotics costing around £114.
One of the UK’s most eminent spinal surgeons said the discovery was the greatest he had witnessed in his professional life, and that its impact on medicine was worthy of a Nobel prize.
…
The Danish team describe their work in two papers published in the European Spine Journal. In the first report, they explain how bacterial infections inside slipped discs can cause painful inflammation and tiny fractures in the surrounding vertebrae.
Working with doctors in Birmingham, the Danish team examined tissue removed from patients for signs of infection. Nearly half tested positive, and of these, more than 80% carried bugs called Propionibacterium acnes.
The microbes are better known for causing acne. They lurk around hair roots and in the crevices in our teeth, but can get into the bloodstream during tooth brushing. Normally they cause no harm, but the situation may change when a person suffers a slipped disc. To heal the damage, the body grows small blood vessels into the disc. Rather than helping, though, they ferry bacteria inside, where they grow and cause serious inflammation and damage to neighbouring vertebrae that shows up on an MRI scan.
The Danish team describe their work in two papers published in the European Spine Journal. In the first report, they explain how bacterial infections inside slipped discs can cause painful inflammation and tiny fractures in the surrounding vertebrae.
Working with doctors in Birmingham, the Danish team examined tissue removed from patients for signs of infection. Nearly half tested positive, and of these, more than 80% carried bugs called Propionibacterium acnes.
The microbes are better known for causing acne. They lurk around hair roots and in the crevices in our teeth, but can get into the bloodstream during tooth brushing. Normally they cause no harm, but the situation may change when a person suffers a slipped disc. To heal the damage, the body grows small blood vessels into the disc. Rather than helping, though, they ferry bacteria inside, where they grow and cause serious inflammation and damage to neighbouring vertebrae that shows up on an MRI scan.
In the second paper, the scientists proved they could cure chronic back pain with a 100-day course of antibiotics. In a randomised trial, the drugs reduced pain in 80% of patients who had suffered for more than six months and had signs of damaged vertebra under MRI scans
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May 4th, 2013, by David Pascoe | patents, red face, telangectasia
There are very few existing rosacea treatments for the broken blood vessels and general red face of rosacea. Historically laser and IPL are the only proven treatments for this rosacea subtype.
In the last couple of years rosacea sufferers have been encouraged by the development of 2 new drugs that could help treat these symptoms (brimonidine and oxymetazoline). These 2 drugs are slowly making their way through the drug development process. Recently we learnt that Sansrosa has been submitted for final FDA approval.
Patent applications can sometimes give a glimpse into the far distances to see new drugs being considered. Patent applications may also show other things like companies staking out intellectual turf. So even though patent application might show interesting developments they might also reveal pure fantasy as far as new drugs are concerned.
Having said all that, a new patent application has emerged that looks interesting as it appears to point to a new drug that could be useful as a treatment for the redness and broken blood vessels of rosacea.
A word of caution is definitely needed here. A patent application is not a clinical trial or medical advice. This application lists a sole participant in custom made topical application of Rapamune.
Rapamune is a serious drug used to help stop organ transplant rejection. The safety information for Rapamune is a cracker. It is not often that the word death is used in typical prescriptions for rosacea treatments!
Topical Rapamycin / Sirolimus Patent
Methods of treating skin conditions exhibiting telangiectasia
Inventors Jeffrey Sugarman
Agent: Dow Pharmaceutical Sciences – Petaluma, CA, US
USPTO Applicaton #: #20130102572
Abstract: The present application relates to methods of preventing or treating skin disorders exhibiting telangiectasia, for example, rosacea exhibiting an erythematotelangiectatic subtype. Exemplary methods comprise administering to a patient a formulation comprising a therapeutically effective amount of an mTOR inhibitor, such as rapamycin, wherein the mTOR inhibitor is the only active agent in the formulation. Suitably, the formulations are topical formulations administered to the face.
Rapamycin (sirolimus), is a macrocyclic triene antibiotic produced by Streptomyces hygroscopicus (see U.S. Pat. No. 3,929,992) that has been shown to prevent the formation of humoral (IgE-like) antibodies in response to an albumin allergic challenge (Martel, R., Can. J. Physiol. Pharm. 55: 48 (1977)), inhibit murine T-cell activation (Staruch, M., FASEB 3: 3411 (1989)), and prolong survival time of organ grafts in histoincompatible rodents (Morris, R., Med. Sci. Res. 17: 877 (1989)).
Rapamycin has been approved by the FDA to prevent rejection of organ transplants, particularly kidney transplants. It has been suggested for use in treating skin conditions, however, limited to immunoinflammatory skin diseases. See U.S. Pat. No. 5,286,730, the disclosure of which is incorporated by reference herein.
…
[0007] In embodiments, methods are provided for treating a skin condition exhibiting telangiectasia comprising administering to a patient a formulation comprising a therapeutically effective amount of an mTOR inhibitor. Suitably, the mTOR inhibitor is the only active agent in the formulation. The methods suitably reduce the telangiectasia and/or erythema.
[0008] In exemplary embodiments, the mTOR inhibitor is rapamycin.
[00010] Suitably the mTOR inhibitor is present in the formulation at a concentration of about 0.5% to about 10% by weight, for example about 1% to about 8% by weight.
Formulation
[00095] Topical Rapamycin Ointment 1%: 40mg of rapamycin was obtained using 40 tablets of RAPAMUNE® (Wyeth-Ayerst) containing 1 mg of rapamycin each. The tablets were crushed using a mortar and pestle and then sifted to remove the colored pieces of tablet coating material. The rapamycin was next extracted from the crushed tablets with three sequential aliquots of acetone by shaking well in a tightly closed glass jar. The aliquots were passed through a filter paper to exclude the tablet excipients, and the filtrate was air dried for at least 8 hours on a glass plate. The resulting pure rapamycin was then incorporated into 4 grams of petrolatum and mixed until homogeneous.
..
[000157] 4. Evaluator performed the IGA for ETR which revealed an IGA of 2 (mild). This represents an improvement of the IGA from a 3 (moderate) to a 2 (mild) in just 2 weeks
[000161] The subject is to be evaluated at specified periods over the course of I , 3, 6, 9, 12, 24, and 48/or months, etc. An improvement from the IGA of 3 (moderate) to 2 (mild) to 1 (almost clear) to 0 (clear) over the study period, and potentially maintaining this improvement, is an indication of the surprising and unexpected reduction in IGA demonstrated by the present formulations
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May 2nd, 2013, by David Pascoe | finacea, minocycline, research, solodyn, tetracyclines
A recent study has highlighted the benefits of the combination therapy of Solodyn and Finacea.
Solodyn is one of the lesser known systemic rosacea treatments.
What is Solodyn?
Solodyn is an extended-release, low dosage of Minocycline, a member of the tetracycline family.
Solodyn is available in 8 strengths. Yes that is right you can get a prescription of Solodyn in 8 different amounts. A doctor can choose a dosage based on your weight in order to maintain a low-dose and extended treatment regime.
The prescribing information for Solodyn tells us that it may take up to 12 weeks to show maximum benefits.
Relationship between Solodyn and Finacea?
There is an arms length relationship between these 2 products. It is worth bearing this in mind when considering why this particular study might have been created in the first place.
Are you ready for the explanation of the link between Solodyn and Finacea? Here we go.
Solodyn is made by Medicis, who is owned by Valeant.
Finacea is made by Intendis, who are part of the Bayer Group.
Valeant Pharmaceuticals has an agreement with their competitor Intendis, to sell Finacea in the UK.
Valeant are also the makers of the CeraVe range of products which is joint marketed with Finacea as Finacea Plus.
So these 2 products are related through their parent companies joint marketing efforts.
Clinical Studies for Marketing Outcomes?
Although this short abstract doesn’t tell us if Valeant, Medicis, Intendis or Bayer were directly involved in the study, it is the sort of study that if successful, would allow new marketing opportunities.
As we saw with Metrogel and Oracea, there are many possible combination therapies that might lead to new sales and marketing possibilities.
Article Abstract
Efficacy of Extended-Release 45 mg Oral Minocycline and Extended-Release 45 mg Oral Minocycline Plus 15% Azelaic Acid in the Treatment of Acne Rosacea.
J Drugs Dermatol. 2013;12(3):292.
J. Mark Jackson MD, Douglas J. Lorenz PhD, and Leon H. Kircik MD
Division of Dermatology, Department of Bioinformatics and Biostatistics, University of Louisville, Louisville, KY Mount Sinai Medical Center, New York, NY Indiana University School of Medicine, Indianapolis, IN Physicians Skin Care, PLLC, Louisville, KY
Rosacea is one of the most commonly occurring dermatoses treated by dermatologists. There are multiple therapeutic options available for the treatment of papulopustular rosacea. Rosacea is an inflammatory condition, classically presenting with flushing and/or blushing along with erythema, edema, telangiectasia, papules, pustules, and nodules of the face.
Minocycline, a member of the tetracycline family, has demonstrated benefit in the treatment of inflammatory lesions in patients with rosacea.
This manuscript highlights the use of a new sustained-release low-dose minocycline 45 mg tablet, with or without azelaic acid, for the treatment of papulopustular rosacea.
..
Extended-release (ER) minocycline was formulated to avoid many of the side effects noted with high-dose minocycline. ER minocycline is produced in a variety of doses for use in acne, and dosing is based on weight. At the time of this study, the lowest available dose of ER minocycline, 45 mg, was delivered as a once-daily oral tablet.
The reasoning behind this study was to demonstrate the efficacy of the lowest possible dose utilizing the anti-inflammatory effects of minocycline in the treatment of patients with papulopustular rosacea, while avoiding the impact and side effects of high-dose minocycline (100-200 g/day). Azelaic acid has been utilized in the treatment of rosacea and was used topically once daily in the comparison group.
The objective of this study was to evaluate the safety, efficacy, and tolerability of ER 45 mg oral minocycline as monotherapy or combined with azelaic acid 15% in the treatment of rosacea.
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April 26th, 2013, by David Pascoe | rosacea cause
Another paper investigating the link between Small Intestine Bacteria Overgrowth and rosacea symptoms has recently been published.
Many of the results in this 2013 letter to the editor of JAAD confirm early discoveries from the 2008 paper from Clin Gastroenterol Hepatol.
The earlier paper concluded that ;
- This study demonstrated that rosacea patients have a significantly higher SIBO prevalence than controls.
- Moreover, eradication of SIBO induced an almost complete regression of their cutaneous lesions and maintained this excellent result for at least 9 months.
Now this 2013 published paper is offering some more results and thoughts on the subsequent importance of the results.
2013 Article Results
- After therapy with rifaximin, complete resolution of cutaneous lesions in 78% of the patients with SIBO was observed.
- Of the patients with SIBO, 28 were treated with rifaximin: 46% reported cleared or markedly improved rosacea, 25% reported moderately improved rosacea, and 11% reported mildly improved rosacea.
- All 4 patients with ocular rosacea and SIBO reported marked improvement
- Rosacea was unchanged in 18% of patients
Study Comments
The introductory paragraph offers the following comment on how the authors think SIBO and rosacea may be related.
SIBO may alter immunity and trigger rosacea by increasing tumor necrosis factor-alfa or other cytokines, suppressing interleukin-17, and stimulating the T helper 1-mediated immune response.
Furthermore, gut bacteria have been shown to mimic immunogens associated with extraintestinal disease (ie, multiple sclerosis).
Article Abstract
Rosacea and small intestinal bacterial overgrowth: Prevalence and response to rifaximin
Journal of the American Academy of Dermatology, Volume 68, Issue 5 , Pages 875-876, May 2013
Leonard B. Weinstock, MD, Martin Steinhoff, MD, PhD
This work was previously presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course in Washington, DC, October 28-November 2, 2011.
A new pathogenic mechanism [for rosacea] was recently suggested after a relationship was observed in a study where 46% of prospective patients with rosacea had small intestinal bacterial overgrowth (SIBO).
After therapy with rifaximin, a nonabsorbed, gut-active antibiotic, complete resolution of cutaneous lesions in 78% of the patients with SIBO was observed
Future Studies Needed
The authors recognise that more research is required to further confirm the efficacy of rifaximin.
The suggested future research would find rosacea sufferers who test positive to SIBO with the lactulose breath test and then are blind tested with rifaximin or placebo.
If the active participants were significantly improved compared to placebo participants then the usefulness of the nonabsorbed, gut-active antibiotic rifaximin would be confirmed.
Study Sponsor
The study was partly funded by Salix Pharmaceuticals, who hold a US Patent for rifaximin and market it under the brand name Xifaxan.
Related Large Clinical Trial
A large randomized clinical trial titled Rifaximin Treatment of Papulopustular Rosacea is due to start shortly. (NCT01359228) will study 100 patients in two groups – the active group to receive a dosage of Xifaxan 550mg, 3 times a day for 14 days – and the inactive arm to receive placebo (and then cross over).
This proposed clinical study is sponsored by University of California, San Francisco.
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April 17th, 2013, by David Pascoe | clinical trials, makeup
Biometrix are looking for trial participants in San Francisco. This trial is looking for Asian Women with facial redness, interested in trying a `mineral treatment pressed powder’. The powder is said to visibly reduce redness on application.
See below for more details.
Biometrix conduct possibly relevant trials each month, so you are in San Francisco and might be interested in future trials, please register at their web site.
Investigatory Product: Treatment Pressed Powder
Description: A mineral treatment powder that visibly reduces facial redness on contact.
Criteria for Qualification
Age: 18-65
Sex: Female
Ethnicity: Asian (Non-Chinese)
Condition: Sensitive Skin, Sensitive Eye/Eye Area, Reactive or Persistent Redness
Start Date: 4/15 (latest 4/22)
End Date: 5/10 (latest 5/14)
Location: 2395 Ocean Avenue, San Francisco, CA 94127
Investigator: Biometrix, Inc. Clinical Testing and Research
Website: www.joinbiometrixinc.com (or Translucent Treatment Powder).
Phone: (415) 239-8006
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