Finding the right practitioner to treat you with IPL is not an easy task. This is a real dilemma for rosacea sufferers as we do know that IPL is Excellent for Rosacea.

Woman scarred by skin treatment

Kate Bastians, The West Australian, Updated January 21, 2012, 3:00 am

Perth women are being left with scars and severe burns caused by amateur beauty therapists performing a popular hair removal and skin treatment without proper training.

A Joondalup woman has told how her chest resembles a chequerboard of excruciatingly painful burns after receiving Intense Pulsed Light treatment for sun spots two weeks ago.

…

The woman, who received the treatment from a woman who had set up a home business, feared she would be scarred for life and wanted to warn others about the complications that may arise from the treatment.

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The WA Australian Medical Association and the Cosmetic Physicians Society of Australasia have called on the Health Department to introduce standards for the booming IPL industry, which is unregulated.

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The Department of Consumer Protection received 21 inquiries and 10 complaints about IPL last year, which included reports of burns and scarring. That was up from 15 inquiries and one complaint in 2010.

Chris Goodwin, director of the Australian College of Beauty Therapy in Perth, said people were buying cheap IPL machines off the internet and using them on people without appropriate training.

"They think it sounds like a great money-making exercise and they get two days training and that’s it," she said. "There are too many cases where people are getting badly burnt and I think the Health Department needs to act."

AMA WA vice-president Richard Choong said there had been an increase in reports of people receiving burns from IPL treatment as it became more readily available.

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Taro Pharmaceuticals in fact already markets a generic form of Metrogel – Metronidazole Gel USP, 0.75%

When the patent covering Metrogel 0.75% expired, Galderma changed the formulation, increased the concentration of metronidazole to 1% and now produces the best-known rosacea treatment, Metrogel 1%.

This is good news for rosacea suffers, who can only benefit from competition in the rosacea treatment staples market. Often rosacea sufferers come away from their first visit to the doctor and pharmacist with one thought – Why is this Metrogel so expensive?

Trial CT01513863 is listed to compare Taro Pharmaceutical’s Generic Metronidazole 1% Gel with Galderma’s Metrogel 1% (and also placebo).

Clinical Trial NCT01513863

A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea (MTZG)

A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multi-Site Clinical Study to Compare the Bioequivalence of Two Metronidazole 1% Topical Gel Formulations in Patients With Moderate to Severe Rosacea

Arm 1

Metronidazole Topical Gel 1%: Experimental

Intervention: Drug: Metronidazole Topical Gel 1%

Arm 2

Metronidazole Topical Gel 1% (Metrogel ): Active Comparator

Intervention: Drug: Metronidazole Topical Gel 1% (Metrogel)

Arm 3

Placebo: Placebo Comparator

Intervention: Drug: Placebo

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• Generic Metrogel soon – Fougera
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Patents are due to shortly expire for Pfizer’s Liptor and Lilly’s Zyprexa. Lilly can expect a $3bn drop in revenue just from generic forms  of Zyprexa becoming available. Pfizer is thought to have earned around $7.8bn from US sales in the 12 months to September 2011.

By comparison, Oracea is thought to have generated sales of $260m in 2011 for Galderma. So even though Oracea is very expensive compared to 50mg of generic doxycycline, Oracea itself being protected by a long-lasting patent is still small-fry compared to giants like Liptor and Zyprexa.

Metrogel 1% is also protected by patents owned by Galderma, so don’t expect to see similar formulations to Metrogel 1% becoming available before they expire. Galderma will naturally enjoy exclusive marketing and write their own pricing of Sansrosa/CDCD07805/47 should that become available as well.

Patent expiries and emerging pharma markets to fuel $100bn generics growth

Published: 17/01/2012

The global generics market is expected to reach $231bn by 2017, led by patent expiries on blockbuster drugs and the growth of emerging markets, according to a new report.

Analysts at Frost & Sullivan also highlighted impact of government cost-cutting measures and say sales of generics will grow by over $100bn, up from the $123.85bn generated in 2010.

Their Generic Pharmaceuticals Market – A Global Analysis report that generics manufacturers will benefit from the patent expiries of blockbusters, with revenues worth $150bn.

Heading up these are Pfizer’s Lipitor, which lost its patent protection in the US at the end of 2011 and is due to lose exclusivity in Europe in May 2012.

Lilly will also be hit hard by generic competition to its antipsychotic Zyprexa (olanzapine), with revenues of the drug expected to fall by $3bn for 2012.

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•  Oracea too expensive ?
• Oracea set to generate $260m in 2011
• Mylan Violates The Chang Patent for Oracea
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Galderma have announced that Metrogel 1% will now be available in a 55gm Pump. Galderma are citing the benefits of a better looking dispenser, minimizing waste, easier compliance with prescribing instructions and “facilitating product handling”. Galderma received FDA approval for Metrogel 1% Pump in October 2011.

Metrogel 1% Pump is now available on prescription in pharmacies across the U.S.

As we know, the Metronidazole market is awash with choices; Metrogel 1%, Rozex, Metrolotion, Metrocream and Noritate – and now Metrogel 1% Pump.

Galderma Announces Availability of New Metrogel(R) 1% Pump Dispenser for the Treatment of Papulopustular Rosacea

Pump Delivery Provides Consistent Dosing, Minimizes Waste and May Help Increase Patient Compliance

FORT WORTH, TX–(Marketwire -01/17/12)- Galderma Laboratories, L.P. today announced the availability of a new pump dispenser design for MetroGel® (metronidazole) Gel, 1%, the most powerful strength of topical metronidazole available in a gel to treat the inflammatory lesions (bumps and blemishes) associated with rosacea. The MetroGel® 1% Pump, which the U.S. Food and Drug Administration approved in October 2011, is now available by prescription to patients in pharmacies nationwide.

Results from a new survey of 207 physician-diagnosed rosacea patients, ages 25 to 65, found 69 percent of patients prefer a pump over a tube. Patients in the survey also felt the pump was more aesthetically pleasing and reported the pump delivery facilitates product handling and storage and minimizes waste. Additionally, patients thought the pump delivery would help them to follow their doctor’s instructions on product usage.

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Happy New Year to everyone who reads Rosacea Support !

As we start 2012 lets look briefly at what was popular in the last year.

Most popular posts in 2011

Following are the 5 most popular posts in 2011 for new comments. All of these posts have been on the blog for a couple of years, proving that they are still interesting after all this time.

1. How to Cure a Red Face (facial erythema or redness) 189 comments
2. How to cure a Red Swollen Nose 114 comments
3. What is the Best Moisturizer for Rosacea ? 118 comments
4. Just How do you Kill Demodex Mites ? 629 comments
5. Clinique Redness Solutions: user reviews 95 comments

New Posts

There were 93 new posts written in 2011 whereas Rosacea News put up 108 new posts during 2010.

Search Terms

Most new visitors came to the blog searching via Google. You may be interested to know that the most popular search terms were;

• rosacea pictures
• rosacea support
• prosacea
• demodex mites
• zenmed reviews
• rosacea treatments over the counter
• ocular rosacea

This list may be surprising to you perhaps, especially if you have never yourself looked for information on these topics.

Even though these were by far the most popular search terms, there are plenty more ! I am often surprised by the hugely varying array of things that people are searching for on the internet. The full list of search terms seems to never end!

Traffic

Overall in 2011 there were around 976,666 Visits, 739,129 Unique Visitors, and 1,927,057 Pageviews. Those numbers all don’t mean too much – but hopefully show that the site contains stuff that people actually want to read.

Looking Forward

I wish everyone a great 2012, with continuing success is everyones’ battle against rosacea.

Even more, I wish for more treatments options, and easily accessible knowledge about existing options.

Thanks for your support of the site,
David Pascoe, January 2012.

• Ferritin positive cells are much more prevalent in rosacea sufferers
• Severe rosacea sufferers have significantly more ferritin positive cells
• Blood peroxide levels are higher in rosacea sufferers
• Total anti-oxidative levels are significantly lower in rosacea patients

The conclusion of the paper is that exposure to UV light results in ferritin positive cells that are fundamental to the resulting oxidative stress.

What is Oxidative Stress?

Oxidative stress has to do with the amount of reactive oxygen species present in our bodies. When there are too many, damage to cell components result.

In broad terms, antioxidants are helpful when the balance is wrong and too many ROS are present.

It is a complicated science; oxidative stress has been linked to many diseases and needs to carefully dissected to understand any real implications for a particular disease.

We do know that rosacea is the end result of an inflammatory pathway. We need to describe the entire system before we can say that we have rosacea licked.

The role of oxidative stress and iron in pathophysiology of rosacea

Lijec Vjesn. 2011 Jul-Aug;133(7-8):288-91.

[Article in Croatian], Tisma VS, Poljak-Blazi M., Poliklinicki odjel za kozne i spolne bolesti, KB Dubrava, Zagreb.

Rosacea is a common skin disease of unknown etiology.

The aim of the present paper is to explain the role of oxidative stress triggered by UV light and iron metabolism in the pathophysiology of rosacea.

It was recently described that the number of ferritin positive cells was significantly higher in skin samples of rosacea patients compared to controls of healthy skin samples.

The presence of ferritin was significantly higher in patients with the severe stage of disease. In addition, serum peroxide levels were significantly higher and serum total antioxidative potential levels were significantly lower in rosacea patients than in healthy controls.

These results support the role of oxidative stress and affected metabolism of iron in etiology of rosacea.

The higher presence of ferritin in skin cells of rosacea patients explains the exacerbation of symptoms by exposure to UV light, that releases ferritin free iron, which is fundamental in the generation of oxidative stress.

This paper appears to be a followup to a 2009 paper , Oxidative stress and ferritin expression in the skin of patients with rosacea, J Am Acad Dermatol. 2009 Feb;60(2):270-6.

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• RSRP: Role of Inflammation
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Galderma has another rosacea-targeted treatment, until now undisclosed, in the final stages of approval. Hey – how come no one told me?

Could it be possible that the rosacea heavyweight Galderma has kept a new product so secret?

What is this CD5024?

Just what exactly is this CD5024 1% Cream? Galderma always give code names to their in-development products, why has no one noticed this new code so far?

I can’t find many clues, but my guess is that CD5024 is a 1% cream formulation of metronidazole.

Read on to see why my guess is that we can pretty much ignore CD5024 as being something new and innovative.

Two Clinical Trials Posted

I was first alerted to the new product CD5024 when two new clinical trials were posted at clinicaltrials.gov. Both of these are Phase 3 Trials, suggesting that the product was in the latter stages of product development.

• Trial NCT01493947 is a Phase 3 trial comparing CD5024 to Metronidazole 0.75% for 16+36 weeks.
• Trial NCT01493687 is a Phase 3 trial proving CD5024 works better than placebo after 12 weeks, for the papules and pustules of rosacea. A further 40 weeks to prove that CD5024 is as safe as Finacea.

So it seems a reasonable guess that as the trials want to compare against Finacea, the concentration is 1% and the target is the papules and pustules of rosacea, that CD5024 is merely metronidazole.

Another reference to CD5024 was from 2006 in an Australian trial. Perhaps this is another hint – Metronidazole in a 1% formulation is not available in Australia, so perhaps this shows that Galderma is preparing a Metrocream 1% for a wide market.

Do We Need Another Metro Sibling?

If I am correct, and CD5024 is merely MetroCream 1%, it will be joining a pretty crowded metronidazole market. Even though you can find Metrogel 1%, Metrogel 0.75%, Metrocream, Metrolotion, Noritate and even Metronidazole with sunscreen, some research suggests that it doesn’t actually matter which you choose, they all work much same. Marketing gone mad? I would suggest so.

Your Thoughts

Do you have any more information about CD5024? Please let us know in the comments below or drop me an email to david AT rosacea-support.org. Thanks.

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Of course we know this treatment as Sansrosa. Other names we have seen over the years include COL-118 and CD07805/47. The active ingredient in the glaucoma treatment of mentioned is Brimonidine Tartrate.

Gel that stops you from getting a red face in middle age

By PAT HAGAN

Last updated at 9:44 PM on 12th December 2011

A new gel could help banish the redness suffered by people with the skin condition.

The gel contains a drug widely used in eye drops to treat glaucoma, the disease that can cause blindness, which works by constricting blood vessels.

When used in the eye, the drug makes blood vessels shrink and reduces pressure that can cause vision problems.

Now researchers have reformulated it into a gel that can make blood vessels in the surface of skin contract, reducing the red and flushed appearance that many rosacea sufferers endure.

Scientists at the University of Louisville, Kentucky, used the new gel on 122 rosacea sufferers once or twice a day for four weeks.

Within 12 hours, there was an improvement in redness, according to results published in the British Journal of Dermatology.

The journal item mentioned in this article is detailed here: Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment of moderate to severe facial erythema of rosacea: results of two multicenter, randomized and vehicle-controlled studies

Related Articles

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Ocular Rosacea: Curse of the Celts and Celebs

The presentation is given by Heather Potter, MD, an Ophthalmologist from the University of Wisconsin School of Medicine and Public Health.

Highlights

Some of the points that I thought were interesting;

• rosacea is not purely related to demodex mites because eradicating them with Lindane (quite a dangerous drug it seems) does not help rosacea symptoms.
• some good slides and description of the life cycle of demodex
• tea tree oil shampoo for lid hygiene as in normal blepharitis treatment is a good option for demodex infestation of the eyelid.
• Tea Tree Oil is the best treatment we have for demodex
• Tea Tree Oil 20% combined with macadamia or walnut oil is another option
• Otophyma gets a mention, with a slide where you are directed to the visible pores in the enlarged ear
• Azelaic Acid 20% is mentioned at a 1st line topical treatment, but I think they actually meant Finacea which is only 15%
• Sodium Sulfacetamide wash as a lid scrub is mentioned as an alternative to baby shampoo
• “Burst and Taper” or just starting out with 40mg a day of doxycycline is mentioned as an oral treatment
• 3000 – 4000 mg Omega 3, tapering to 2000 mg a day maintenance has worked well for her ocular rosacea patients. It takes 6 weeks to have an effect.
• Ocular rosacea is found equally in males and females.
• Cyclosporin gets a mention as a topical treatment. Azasite Plus drops (a steroid plus azithromycin) is shown on the topical treatments slide.
• Need to raise the body temperature by 5 degrees before attempting warm compresses to liquify the meibomian gland secretions you are trying to clean.
• Cyclosporin gets another mention for dry eyes, along with punctal plugs
• Doxycycline gets a mention specifically as an ocular rosacea treatment
• An image from a “throw away journal” with what looks like a device to heat and massage the eyelids to help clear the glands.

The video is 25 minutes long, but you can squash it down to 16 minutes if you select the 1.5x link at the bottom of the video player.

Well worth a watch.

Best Bit for You?

What bit of the video was most worthwhile for you?

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We know that the pH of skin is around 5.4. The makers of Finacea, Intendis have formulated Finacea to be pH of 4.8, which means that Finacea is reasonably close to the same pH as skin. One of the ingredients of Finacea is sodium hyroxide, which is alkaline, so can be used to adjust the pH of the final formulation.

By comparison, Metrogel Vaginal has a pH of about 4.0, I was unable to find the pH for Metrogel 1%.

The following research found that an azelaic formulation of pH 4.9 was substantially more effective at delivering the active agent (azelaic acid) to the dermis and epidermis, compared to a pH 3.9 formulation.

Intendis tell us that Finacea has pH-adjusted to around 4.8 and thus Finacea shows "No interference with physiologic pH of skin acid mantle. Optimum pH for formulation consistency".

Effect of ionization and vehicle on skin absorption and penetration of azelaic acid

Drug Dev Ind Pharm. 2011 Nov 23, Li N, Wu X, Jia W, Zhang MC, Tan F, Zhang J.

Tianjin Key Laboratory of Drug Delivery & High-Efficiency, School of Pharmaceutical Science and Technology, Tianjin University , Tianjin, PR China.

Objective: The aim of this study is to investigate the effect of ionization and vehicle of topical formulations on skin absorption and penetration of azelaic acid (AZA).

Materials and methods: In vitro transport of AZA was determined for two topical formulations containing AZA with pH values of 3.9 and 4.9, respectively. FINACEA(®) (15% AZA gel), a US Food and Drug Administration approved drug for treatment of acne and rosacea, was also used for comparison. Release profile and flux of AZA were determined in an in vitro hairless mouse skin model using Franz Diffusion Cell.

Results: The data have shown that a higher concentration of AZA is retained in the epidermis/dermis layer and the whole skin for the formulation with pH = 4.9 as compared to that with pH = 3.9 at an active loading level of 2.82 mg/cm(2). In addition, the flux of ionized species of AZA in the pH 4.9 formulation (128.4 ± 35.9 μg/cm(2)/h) is approximately five-fold greater than that in the pH 3.9 formulation (27.7 ± 4.0 μg/cm(2)/h). The results suggest that the ionized AZA penetrates through the skin and accounts for majority of the total flux.

Discussion and conclusion: This study has demonstrated that the penetration and absorption of AZA show a strong pH- and vehicle-dependency. Solubilization is the rate-limiting step in percutaneous absorption of AZA.

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• Finacea Foam being trialled
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