One of the up and coming treatments for the redness of rosacea is the use of oxymetazoline based formulations.

Oxymetazoline is the active ingredient in decongestant products like Afrin, Sudafed OM and Vick Sinex as well as in eye drops like Visine LR.

Recent publicity from Vicept Therapetics suggests that their product in development V-101 contains the active ingredient oxymetazoline.

A well known side effect of Visine is rebound redness, where continued use leads to the redness that you were originally treating. Extended usage of Afrin can also lead to rebound nasal congestion.

Rebound redness with eyedrop use

PEOPLE’S PHARMACY

Oxymetazoline is a long-acting topical drug that constricts, or shrinks, blood vessels. That is how it relieves congestion in the nose. But people who use nasal decongestants for allergies, colds or sinus problems are warned to use such products for only three to five days. After that they may experience rebound congestion as the medicine wears off.

The same thing can happen in the eyes. Rebound redness occurs when the blood vessels dilate after the effects of the medicine fade. It can take several days (or sometimes longer) for this effect to gradually disappear. You may be better off with artificial tears rather than anti-red drops.

For any oxymetazoline based treatment to succeed as a treatment for a chronic condition like rosacea (i.e. rosacea isn’t a condition that goes away after just a couple of days), the promoters will need to prove that their formulations are safe for use in the medium to long term.

A 2007 paper Successful Treatment of the Erythema and Flushing of Rosacea Using a Topically Applied Selective α1-Adrenergic Receptor Agonist, Oxymetazoline attempted to answer this questions thus;

Neither of our patients exhibited either problem with the application of oxymetazoline to the skin. While the laboratory induction of receptor desensitization cannot yet be perfectly correlated with actual physiologic response, recent laboratory studies indicate that agonists that are more selective for α1D-adrenoceptors are less prone to induce receptor desensitization than are α1A- or α1B-agonists. The clinical significance of this may be an important consideration in contemplating any potential future use of these drug classes on the skin because agonists with certain receptor subtype binding profiles may retain their clinically desirable effects while minimizing their adverse effect.

(emphasis mine)

You can download a full copy of this article from the Archives of Dermatology website; Successful Treatment of the Erythema and Flushing of Rosacea Using a Topically Applied Selective α1-Adrenergic Receptor Agonist, Oxymetazoline

So we all wait to see how the trials of V-101 prove performance with extended and intermittent usage of oxymetazoline.

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The trial will study the efficacy of V-101 Cream, applied once per day, at a low dose of 0.01%, 2 lots of mid-dose of 0.06% and 0.1%, as well as a high dose of 0.15%.

The active ingredient in the formulation has not been officially disclosed, but a reasonable guess is that the active is oxymetazoline. The patents held by the company suggest that oxymetazoline is a primary active of interest, and further confirming the active ingredient is an exclusion criteria for this trial that precludes the “use of products containing oxymetazoline within 14 days of baseline”.

Oxymetazoline is the active ingredient in over the counter products such as Afrin, Vicks Sinex and Visine. The potential side effects of oxymetazoline when applied topically include rebound redness, hypertension and palpitation.

It will be interesting to see how well oxymetazoline performs in a double blind trial as well as get an understanding of any rebound redness and also whether any rebound redness occurs when continuing to use oxymetazoline after having a break.

Here is a short extract of the just announced trial;

Dose Response Study of Patients With Erythematous Rosacea

The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous (redness) rosacea.

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• oxymetazoline may be good for 2 years
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• Dermatology Times highlights Afrin and Sansrosa

Now that a company name has surfaced we can put the pieces together back to 2007 when Rosacea News featured a publication that suggested that a viable alternative to Sansrosa was about to compete in the anti-redness race. The author of that paper, Dr. D. Shanler is a holder of multiple patents relating to alpha adrenoceptor agonists and treating skin conditions.

While it can’t be said for sure that V-101 is oxymetazoline, it is encouraging to see a product of this sort slowly making its way through the drug development cycle.

V-101 was found to offer a benefit to the redness of rosacea, and was not detectable in the blood of users.

Vicept Therapeutics Announces Positive Clinical Study Results of V-101 for the Treatment of the Erythema of Rosacea

MALVERN, Pa., Aug. 5 /PRNewswire/ — Vicept Therapeutics, Inc., a privately held specialty biopharmaceutical company, announced positive results today from a pharmacodynamic and pharmacokinetic clinical trial of the Company’s lead product V-101, a topical cream under investigation for the treatment of erythema in patients with rosacea.

The double-blinded, placebo-controlled, crossover clinical trial of 22 patients with rosacea was designed to evaluate the bioavailability of V-101 and provide preliminary evidence of efficacy as measured by improvement in moderate to severe erythema, the bright redness of the skin associated with rosacea.  V-101 had a side effect profile similar to placebo and V-101′s active ingredient was not detectable in study participants’ plasma, a strong indication of the product’s overall tolerability and safety profile.  Additionally, the study results were positive for all endpoints, demonstrating a clinically and statistically significant improvement in treating the erythema associated with rosacea.

“This important study demonstrated that V-101 has a good safety profile and provides statistically significant evidence of effectiveness in treating the erythema of rosacea,” said Dr. Neal Walker, president and chief executive officer of Vicept. “We look forward to advancing our clinical program into Phase II and continuing our efforts to develop this product for the 16 million people in the United States who live with this common, chronic skin condition every day.”

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Vicept Therapuetics is based in Malvern in Pennsylvania and is a privately held company.

From Fidelity Biosciences Joins $10M Series A for Vicept Therapeutics

“We are delighted by the strong investor interest in this round of financing which will allow us to continue to advance the development of our product pipeline utilizing our novel, patent protected α-adrenergic receptor technology for the treatment of diseases of the skin,” added Dr. Walker. “With this investment, we will have the necessary resources to continue progress with our lead candidate through Phase II for rosacea as well as pursuing other dermatologic conditions including actinic purpura and peri-procedural bruising of the skin.”

Great to see another company getting funding to develop new treatments for rosacea. Obviously there is a belief by venture capitalists that rosacea is a growth market, especially for the treatment for erythema.

The following patent looks likely to be related to the company and their product development.

COMPOSITIONS AND METHODS FOR TREATING PURPURA

(WO/2009/065116)

PCT/US2008/083774

VICEPT THERAPEUTICS, INC

SHANLER, Stuart D; ONDO, Andrew

Embodiments of the present invention are directed to compositions and methods for the treatment of purpura. Preferred compositions comprise an α adrenergic receptor agonist selected from selective α₁ adrenergic receptor agonist, selective α₂ adrenergic receptor agonist, non-selective α₁/α₂adrenergic receptor agonist, agents with α₂ adrenergic receptor agonist activity and combinations thereof, in a pharmaceutically acceptable carrier in order to treat and improve the cosmetic appearance of hemorrhagic (purpuric) lesions in the skin.

The authors of this 2009 patent describe some trials where the following formulations were trialled;

• Oxymetazoline hydrochloride from Afrin Original 12 Hour Nasal Spray
• Naphazoline hydrochloride from Clear Eyes Maximum Redness Relief
• Tetrahydrozoline hydrochloride from Visine Original
• Phenylephrine hydrochloride from Neo-Synephrine Extra Strength Spray
• Brimonidine tartrate from Bausch & Lomb
• Oxymetazoline hydrochloride and brimonidine tartrate combined.

The results of this trial claimed;

… that this demonstrates that selective αi adrenergic receptor agonists and selective α₂ adrenergic receptor agonists, used separately or in combination, when topically applied to and around a treatment site after a procedure that can/will induce purpura, will reduce the size and appearance of the purpuric macules/ patches and is an effective treatment to hasten their resolution.

The source of the purpura in this instance was a pulse dye laser at 585nm.

The publishers of this patent have an additional similar patent that was mentioned by Rosacea News  in 2007;  Sansrosa’s sister to enter redness race

Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using a1-adrenoceptor agonists

United States Patent Application 20050165079

Shanler, Stuart D.; (New York, NY) ; Ondo, Andrew; (Las Cruces, NM)

The present invention is directed to the treatment of skin erythema as exhibited in rosacea and other conditions characterized by increased erythema (redness) of the skin. These conditions exhibit dilation of blood vessels due to a cutaneous vascular hyper-reactivity. In particular, the present invention is directed to a novel composition and method for the treatment of skin erythema using .alpha..sub.1-adrenergic receptor (.alpha..sub.1-adrenoceptor) agonists incorporated into cosmetic, pharmacological or dermatological compositions for topical application to the skin.

Whilst it appears that no new molecules have been discovered, these patents, if allowed, will protect the usage of these formulations to treat the redness of several skin conditions including rosacea. As we have seen with the Sanrosa product it can take many years and a large investment in R&D to progress from a discovery to a sellable product. It is great news that Vicept has secured funding to begin this drug approval process.

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La Roche-Posay are not particularly well known in the rosacea world but they do sponsor the National Rosacea Society and have a range of products, called Rosaliac, that targets rosacea sufferers.

The company is taking the opportunity of the rosacea awareness month and their support of the NRS to promote a new product – Rosaliac UV Fortifying Anti-Redness Moisturizer with SPF 15.

The ingredients of this product are hard to find, all I can see is the generic “a patented combination of ingredients including Vitamin CG, Xanthine and thermal spring water to help neutralize visible redness” as well as a “patented broad spectrum filtering system to help protect against UVA and UVB rays”.

The ingredients for the related Rosaliac Skin Perfecting Anti-Redness Moisturizer are listed here: Rosaliac with xanthine, vitamin CG & B3. We would need to know what La Roche-Posay have included to add broad spectrum sun protection before giving it a tick for rosacea sufferers.

Rosaliac (apparently the range with the highest loyalty in the La Roche-Posay offering) is said to provide an instant relief of visible redness due to a light green tint. This sort of approach might not be to all rosacea sufferers’ liking. How do you find this product ?

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A previous study in 1994 also found that Vitamin K cream reduced the severity of post PDL purpura.

Whilst the redness and indeed purpleness that Pulsed Dye Laser treatments can cause will heal without intervention, any option to reduce the downtime after treatment will be welcomed.

Pulsed Dye Laser treatments can also be extremely painful. A 2009 paper detailed the use of Pnuematic Skin Flattening to reduce the pain of PDL.

Topical formulations of Vitamin K Oxide are currently available via some doctors and indeed online. A product range from Biopelle known as Auriderm suggests the following to support the promotion of its’ products; “It’s the Vitamin K Oxide – not the Vitamin K – that clears unwanted discoloration and builds vasculature. Vitamin K was effective because it provided the raw material to create Vitamin K Oxide, which really did the work.”

The science of Vitamin K Oxide

Vitamin K has shown effectiveness in dealing with this because it initiates the Vitamin K cycle of healing: In the event of trauma, Vitamin K converts to Vitamin K Oxide, activating the Coagulation Factors in the clotting cascade. The cycle continues when Vitamin K Oxide converts back to Vitamin K, converting the staining ion (Fe+3) to the more easily absorbed ion (Fe+2), blocking and/or reversing the formation of hemosiderin.

Vitamin K itself is inherently unstable in topical formulations, perhaps explaining why Vitamin K topicals so far haven’t to date shown huge promise as rosacea treatments.

It is also worth noting that is has been shown that some people are allergic to Vitamin K. Also note that Auriderm suggests that Arnica Montana tablets be taken post-operatively, but some caution may be advised – Paula Begoun, in her article, When Blushing is Not by Choice: Causes and Treatments for Rosacea (web archive link), lists Arnica as something that potentially should be avoided.

Finally a related word of warning from a 2007 Scientific Committee on Consumer Products opinion on Vitamin K1 (phytonadione) suggested that;

Because of the inadequate nature of the dossier submitted, the SCCP is unable to provide an adequate safety evaluation for the use of vitamin K1 (phytonadione) and its "oxide" in cosmetic products. However, as such use may cause cutaneous allergy, individuals so affected may be denied an important therapeutic agent.

Now to the Abstract:

The role of topical vitamin K oxide gel in the resolution of postprocedural purpura.

J Drugs Dermatol. 2009 Nov;8(11):1020-4.

BACKGROUND AND OBJECTIVE: Facial purpura is a frequent barrier to patient acceptance and satisfaction with the results of various cosmetic procedures. Methods to shorten the duration of purpura after such procedures are often sought by patients. This study evaluated the efficacy and safety of a topical gel containing vitamin K oxide in the resolution of laser induced purpura.

METHODS: In this randomized, double-blinded, placebo-controlled split-face study, 20 subjects with bilateral facial telangiectasia were treated with a pulsed dye laser (PDL) device at purpuric settings. The test articles, a gel containing vitamin K oxide and placebo (vehicle), were each randomly assigned to one side of the subject’s face. Subjects applied the test articles twice a day for the following 9 +/- 1 days. Improvement in both focal and general field purpura on each side of the face was assessed by the investigator using photographs. A scale of -100% (worsening) to 100% (improving) was used to rate photos against a baseline photograph obtained 15-30 minutes after treatment with the PDL device.

RESULTS: Resolution of the field of purpura was consistently greater with the vitamin K oxide gel after the second day of treatment. The greatest difference between the vitamin K oxide gel and placebo scores occurred on the fourth day after treatment. Although differences in active versus placebo scores did not reach statistical significance during the nine-day study period, a trend toward faster resolution of purpura with the active product was seen. Treatment-related adverse effects were not observed in any subject.

CONCLUSION: Vitamin K oxide gel appears to hasten the resolution of pulsed dye laser-induced purpura in subjects being treated for bilateral facial telangiectasia, and may well be useful in accelerating resolution of facial bruising from other cosmetic procedures such as fillers used for soft-tissue augmentation as well as other types of cutaneous surgical procedures

As there are so few genuine treatments for the redness of rosacea, the availability and promotion of Vitamin K Oxide may lead to some interesting and useful options for rosacea sufferers.

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The aim of this trial is show which strength is the most suitable for general use. Trial participants will be using one of 4 different strengths: 0.07%, 0.18%, %0.50 or effectively %0 contained in the gel vehicle. This trial should be completed by the end of the year, paving the way for an eagerly anticipated FDA approval in 2010.

Rosacea News previously found a patent application listing the full ingredients for Sansrosa, which included a mention of the active ingredient Brimonidine tartrate at a concentration of 0.18%. This trial suggests that Galderma is now also interested in a almost 3 times as strong version of %0.50.

The trial details again confirm that Sansrosa is to be applied once per day and that benefits can be expected for up to 12 hours after application. The patent related to the Sanrosa product itself suggested that typical usage was 1-4 times per day.

Galderma is looking for 112 participants, and the register suggests that residents of Pennsylvania, Texas, Virginia  and Arkansas are eligible. Please do post below if you get to be a part of this final phase of testing.

Galderma acquired the Sansrosa product through their acquisition of Collagenex. Rosacea News has been following this product for several years now, since Collagenex first started talking about a new product COL-118, in 2006.

Galderma is now back at one of the Phase II tests for a new drug. This seems disappointing given that Phase 2 Trials were thought to completed in August 2007 and Phase III was slated to commence in early 2008. One can only speculate that Galderma wasn’t satisfied with the progress and likely success of sansrosa and has sent it back for further testing.

It has been a long slow process, but it is encouraging to see that Galderma is still investing in developing this much-awaited product.

Read more of my extensive coverage of Sansrosa News.

Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.

Update: the Dose-Finding has now completed. Note that these trials are part of the Phase II of development of sansrosa. Before a new drug can be approved by the FDA, Galderma must  conclude well-controlled Phase III trials and/or Long Term safety studies.

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The red swollen nose of rosacea is a much hated symptom. I know that this was the symptom that I despised most and indeed drove me 10 years ago to start to look for good information about how to treat rosacea. Incidentally, this drive lead to the creation of the internet based Rosacea Support Group in 1998.

I hated that I looked like I had adult acne and a constant sun-burned nose. Especially as I have somewhat fair skin, a red nose stood out a mile away.

There has been quite a lot of interest in a article I wrote titled “how to cure a red face (facial erythema or redness)“. That article gave some tips on how to deal with general facial redness. What about a red and swollen nose ? What can you do to treat a red rosacea nose ? Read on for some suggestions.

A rosacea nose has the extra complication that one might end up suffering from rhinophyma. Although rare, rhinophyma is also a much hated symptom of rosacea. While we don’t know for sure how any particular rosacea sufferer’s symptoms will progress, reducing your inflammation and flushing is a good start to winning the battle.

Here are my top tips for dealing with the red nose of rosacea.

Rosacea-LTD III

Rosacea-LTD was one of my first discoveries after starting to look for treatments on the internet in 1998. They consist of compressed disks of sulfur and various salts. You wet your face and glide them over the skin, leaving a thin film. For me these `disks’ did a great job of reducing the papules and pustules on my nose. I could feel them shrinking all those acne looking lumps and bumps. As much of my redness was associated with my papules and pustules, this treatment was a good step in the right direction. I continued to use rosacea-ltd for several years.

Disclaimer: rosacea-ltd is a site sponsor of rosacea-support.org

Oral Antibiotics

If the nasal swelling is associated with the papules and pustules normally seen in rosacea, then systemic antibiotics along with topical metrogel or finacea may also be of benefit. Once the papules and pustules are under control, the associated swelling may be reduced enough to see an overall benefit in appearance. One of the newer antibiotics on the market is a low dose form of doxycycline called Oracea, which may be useful in helping to maintain a long term benefit from antibiotic usage.

Accutane

Accutane or roaccutane has been used for many years to treat cystic acne. There is a good body of evidence to say that you can successfully treat rosacea with accutane. Additionally there are some published papers that deal specifically with treating rhinophyma with accutane.

Isotretinoin has also been demonstrated to decrease nasal volume in rhinophyma. The most significant regression has been noted in younger patients with less advanced disease.

…

Isotretinoin has also been demonstrated to decrease nasal volume in rhinophyma. The most significant regression has been noted in younger patients with less advanced disease.

Biopsy specimens from phymatous skin prior to isotretinoin therapy showed numerous large sebaceous glands. During isotretinoin therapy, the glands diminished in size and number. Other studies have confirmed the usefulness of isotretinoin for phymatous change.

[See treating rhinophyma with accutane]

Accutane is not a drug to be taken lightly. If you would like to try this as an option, the above references might help you find a doctor that can support you using this as a treatment option. You may also want to discuss the option of low-dose accutane with your doctor.

Covering Up

As you start to reduce the inflammation, you will probably also benefit from covering over some of the redness. Some options include the easily available Clinique Redness Solutions, or Eucerin Redness Relief which may be able to offer some relief from the redness. Additionally the green tinted version of the Tone Perfecting Cream may cover some redness.

Perhaps you can find some foundation or tinted moisturizer that you can also include in your daily regime. It might not be easily obtainable worldwide, but The Cancer Council in Australia has a range of tinted moisturiser SPF 25 that looks interesting. Don’t discount a liquid foundation as a possibility, even if you are a guy.

IPL and Lasers

We now know that IPL is excellent for treating a red face and broken blood vessels. Will any of the benefits of IPL also help a red swollen nose ? In general IPL and pulsed dye lasers are useful in reducing the redness flushing, burning,  itching, dryness and swelling of rosacea.

The AAD suggests that for thickening of the skin on the nose and cheeks as seen in rhinophyma, the CO2 laser and erbium:YAG laser can be used.

Surgical Options

When the growth of the nose tissue becomes impossible to manage with topicals or isotretinion, surgical intervention can be an option. Surgery can naturally have its own risks. With the removal of extra tissue also comes the risk of scarring.

CO2 Laser

A 2004  paper; The Gold Standard for Decortication of Rhinophyma: Combined Erbium-YAG/CO2 Laser, details how the authors suggest that the combined YAG/CO2 laser is superior to other lasers, scalpel, radiotherapy and skin grafts in dealing with rhinophyma.

Also some related comments from the AAD page Is laser treatment right for your rosacea? ;

Some patients with longstanding rosacea develop thickening skin on the nose and cheeks, which is called rhinophyma. The CO₂ laser and erbium:YAG laser can be used to remove this thickening skin and improve the contour of the nose. Other surgical procedures used to treat this condition include dermabrasion and excision with a scalpel. Treatment options may be combined to obtain best results.

Dermatologists recommend early treatment of rhinophyma to help prevent the condition from progressing and becoming more difficult to treat. In the advanced stages, rhinophyma can cause difficulty breathing through the nose. It also is possible for the nostrils to collapse.

Other Surgical Methods

A 2003 paper; New surgical adjuncts in the treatment of rhinophyma: the microdebrider and FloSeal details a novel technique using a standard microdebrider followed by a haemostatic sealant to eliminate bleeding.

Now Over to You

What have you found to be useful in your battles with a red nose ? Please help your fellow rosacea sufferers by leaving a comment below.

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The dermatology news sheet Dermatology Times has published an item to their web site about the emerging use of oxymetazoline to treat the redness and flushing associated with rosacea. This article draws from the Nov. 2007 paper that introduced us to the possibility of treating rosacea with oxymetazoline.

We also know from the Feb. 2008 meeting of the AAD that oxymetazoline is effective for up to 6 hours after application, and that no negative side effects have been seen after 3 months usage. Further comments here in the DT article extends the apparent `durable’ treatment period to 2 years. Note that this successful long term avoidance of rebound whilst using oxymetazoline refers to just one patient.

Dr. Shanler notes that loss of effectiveness and rebound dilation is a problem associated with the use of intranasal use of oxymetazoline.

Oxymetazoline is classified as a alpha-1 Adregenic Receptor Agonist, whereas COL-118/Sansrosa is a alpha-2 Adregenic Receptor Agonist. According to this DT article oxymetazoline is “also partially selective for the alpha 2a receptor.”

The paper’s authors are both corporate officers of Aspect Pharmaceuticals, who are now planning more formal studies to evaluate rosacea friendly formulations of oxymetazoline and other alpha-1 adrenergic agonists to treat the redness and flushing of rosacea.

From: Taking the red out of rosacea: Topical alpha-1-adrenergic receptor agonist shows promise

Limited experience in a small number of patients indicates that the erythema and flushing associated with rosacea may be safely and successfully treated with topical application of a selective alpha 1-adrenergic receptor agonist, such as oxymetazoline, researchers say.

…

“The results achieved with topical oxymetazoline are exciting, but very early, and they need to be confirmed through more rigorous studies,” Dr. Shanler tells Dermatology Times.

Patient responses to topical oxymetazoline were based on direct clinical assessment and review of high-resolution digital photographs taken pretreatment at one, two to three and 24 hours post application, and then again after longer-term treatment. The evaluations showed topical oxymetazoline had a rapid effect in reducing erythema.

With continued treatment, which extended up to two years in one patient, the responses remained durable, with no evidence of tachyphylaxis, rebound or adverse events.

“Loss of efficacy due to receptor desensitization and rebound vasodilation is a problem associated with use of intranasal oxymetazoline and other imidazoline- and amine-class nasal decongestants.

“There is some laboratory evidence that the potential for receptor desensitization varies depending on the agonist’s selectivity for different alpha-adrenoreceptor subtypes and its duration of action. This may be a consideration in the development of a dermatologic medication that will provide optimal efficacy with minimal risks,” Dr. Shanler says.

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This paper looks to be suggesting that the silymarin/msm containing topical, rosacure/synchrorose was well tolerated and helps with the redness of rosacea. Silibinin (INN) (silybin, Legalon®) is the major active constituent of silymarin, the mixture of flavonolignans extracted from plant Milk thistle. Methylsulfonylmethane (MSM, or dimethylsulfone) is an organic sulfur compound belonging to a class of chemicals known as sulfones.

Rosacure has received only gentle reviews from rosacea sufferers, but as this study was double blind, there may indeed be some small benefits seen as detailed in this study.

Combined effects of silymarin and methylsulfonylmethane in the management of rosacea: clinical and instrumental evaluation, J Cosmet Dermatol. 2008 Mar;7(1):8-14., Berardesca E, Cameli N, Cavallotti C, Levy JL, Piérard GE, de Paoli Ambrosi G. ,San Gallicano Dermatological Institute, Rome, Italy.

Objective: This study aims to evaluate a topical treatment based on silymarin/methylsulfonilmethane (S-MSM) to improve erythematous-telangiectactic rosacea.

Methods: Forty-six patients affected by stage I-III rosacea entered this double-blind, placebo-controlled study. Subjects were treated for 1 month. Clinical and instrumental evaluations were done at baseline, after 10 and 20 days, and at the end of the study. Itching, stinging, erythema, and papules were investigated clinically as well as hydration and erythema instrumentally with capacitance and color measurements.

Results: A statistically significant improvement was observed in many clinical and instrumental parameters investigated (P < 0.001). In particular, improvement of skin redness, papules, itching, hydration, and skin color occurred.

Conclusions: The combination of silymarin and S-MSM can be useful in managing symptoms and condition of rosacea skin, especially in the rosacea subtype 1 erythemato-telangiectatic phase. The action can be considered multicentric and multiphase because of the direct modulating action on cytokines and angiokines normally involved and up-regulated in the case of such skin condition.

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