November 20th, 2009, by Digital Davo | clinical trials, metrogel, topicals
The Clinical Trials register has listed a just completed trial for something cryptically called 0444 Gel. The Gel is targeted for the papules and pustules of rosacea. Apparently the study started in January 2008 and has just been completed.
Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea
Sponsor: Nycomed US Inc
The aim of this trial is to assess the efficacy of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea.
Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.
So what could this gel be ? As far as I can see, likely candidates include Solaraze as well as a new generic form of metrogel. These two classes of products are manufactured by companies related to or owned by Nycomed.
Solaraze
We learnt from a 2006 AAD Poster Session that Solaraze was being studied as a treatment for rosacea. SOLARAZE (diclofenac sodium-3%) Gel is indicated for the topical treatment of actinic keratoses (AKs).
SOLARAZE Gel is a registered trademarks of PharmaDerm, a Division of Nycomed US, Inc.
Solaraze is currently marketed in the US, Europe and Australia.
Generic Metrogel
Nycomed has a sister division Fougera Generics. A press release in 2005 alterted us to the fact that Fougera was poised to make generic metrogel 0.75%. Indeed you can find details on Fougera’s web site for Metronidazole Topical Lotion 0.75% (compares to MetroLotion) and Metronidazole Topical Cream 0.75% (compares to MetroCream).
Other Guesses
Any other guesses ? If you have more information about 0444 Gel please post in the comments below.
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November 18th, 2009, by Digital Davo | accutane, doxycycline
A summary from a the recent 18th Congress of the European Academy of Dermatology and Venereology has presented some findings relating to the most effect dosage of accutane to treat rosacea.
Accutane (Isotretinoin) has been successfully prescribed in low doses to treat rosacea, and especially the `lumps and bumps’ of rosacea that have not responded to other treatments.
Despite some good published papers that deal with treating rosacea with low doses of accutane, officially isotretinoin needs to be prescribed `off label’ for treating rosacea.
For those enrolled in this blind study, 0.3 mg/kg per day was found to be as effective as 50mg a day of doxycycline at treating the papules, pustules and phymatous growth of rosacea.
Getting the dose right is important if you want to try Isotretinoin as a treatment for your troublesome rosacea. How do you know if you are taking too much ? A high dose of accutane can lead to unpleasant side effects and even worsen the flushing associated with rosacea.
If you consider an average weight of 166 pounds (around 75kg) this paper would lead to a recommended dosage of around 22mg a day. Even this amount may be viewed as moderate to high when compared to advice from Dr. Plewig that “doses of isotretinoin typically used in the United States and Europe are far too high. For many patients, as little as 2.5 mg twice a week, which he describes as `a drop of rain on a dusty road’ is adequate.”
Dr. Erdogan et.al. suggested that “In our small group, using a daily dose of 10 mg of isotretinoin, we did not observe such adverse effects. Although we selected patients resistant to treatment with a long history of complaints, our results confirmed the efficacy of isotretinoin use, but whether remissions will continue after the cessation of treatment is not addressed by our study.”
Further, advice from Dr. Hofer suggests doses of around 3mg to 8mg in what he calls his continuous microdose regime are suitable for treating rosacea. In 2000, Palmer et al. showed that continuous microdose isotretinoin (CMI) treatment (0.04-0.11 mg/kg daily) was sufficient to control adult relapsing acne, but they mentioned that this is an unlicensed method administration.
This paper will hopefully give some weight to the argument that under controlled circumstances, in the right doses, and for the indicated rosacea symptoms, low dose accutane can be a viable treatment.
If indeed this research helps lead to accutane being available as an on-label prescription for rosacea sufferers, then that is good news especially for those desperate for relief from the recalcitrant lumps and bumps of rosacea.
Optimal Isotretinoin Dosing for Rosacea Identified
BERLIN (EGMN)–Isotretinoin could be headed for a new indication as a licensed treatment for rosacea.
The workhorse oral retinoid has been used off label to treat challenging cases of rosacea for more than 2 decades. However, Barcelona-based Almirall recently sponsored a successful multicenter randomized trial aimed at earning an indication from regulatory authorities for its branded version of isotretinoin in the treatment of rosacea, Dr. Harald Gollnick said at the annual congress of the European Academy of Dermatology and Venereology.
The double-blind, 12-week study involved 224 patients with the papulopustular or phymatous forms of rosacea. Participants in the five-armed trial were randomized to isotretinoin at 0.1, 0.3, or 0.5 mg/kg per day; doxycycline at 100 mg per day followed by 50 mg per day; or placebo, explained Dr. Gollnick, professor of dermatology at Otto-von-Guericke University, Magdeburg, Germany, and president of the European Board of Dermato-Venereology.
The optimal isotretinoin dose proved to be 0.3 mg/kg per day. Its efficacy was superior to placebo and similar to that of doxycycline, with both regimens achieving a 90% reduction in papules and pustules at 12 weeks, according to Dr. Gollnick, who is also chairman of the Global Alliance to Improve Outcomes in Acne, an international group of acne experts.
“That means in the near future we’ll most probably have an on-label indication for isotretinoin in rosacea,” he said.
Over the years isotretinoin has been used off label to treat rosacea, but the best dose was a matter of guesswork. The Almirall-sponsored trial is particularly welcome because it is the first formal study aimed at defining the optimal dose, added Dr. Gollnick.
The 0.3 mg/kg dose was associated with a low rate of side effects, consisting mainly of mild lipid changes and liver enzyme elevations. The 0.5 mg/kg dose wasn’t any more effective, and it produced more irritation and facial dermatitis. The 0.1 mg/kg dose, while significantly better than placebo, was less effective than 0.3 mg/kg.
Topical therapies for rosacea include 0.5%-2% metronidazole, azelaic acid, 0.025% tretinoin, and 2.5%-5% permethrin. Systemic treatments include metronidazole at 500 mg/day, minocycline at 50 mg/day, tetracyclines at 0.5-1.5 g/day, and a subantimicrobial formulation of doxycycline.
Over to You
What dose of accutane have you found to work best for you ?
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November 13th, 2009, by Digital Davo | laser therapy, red face
A recently published paper is proposing the use of Vitamin K Oxide (Phytonadione Epoxide Hexane) as a treatment to accelerate the recovery from the redness and purple lesions following Pulsed Dye Laser.
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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November 12th, 2009, by Digital Davo | acne treatments
News today that Sol-Gel Technologies has filed for Investigational New Drug for a product they are calling DED45-EV. This topical gel is targeted as a treatment for rosacea.
There doesn’t seem to be other copies of this release, or related information so this could just be a pure PR exercise.
The exact details of the active ingredients in this product are not being made public. So far, only PR speak along the lines of ““As Sol-Gel’s microcapsulation forms a protective barrier between the drug and the skin, we expect it to reduce irritation when applied to the relatively sensitive skin of rosacea patients,“said Dr. Stanley Shapiro, Sol-Gel’s Head of Skin Care Science & Technology.” is being published.
My guess back in July in Sol-Gel Trialling Benzoyl Peroxide (DER 45 EV) for Rosacea ? was that this topical gel was in fact benzoyl peroxide. Certainly the publicity so far from Sol-Gel has been related to acne and acne treatments.
Sol-Gel Anti-Acne Clinical Study Shows Significantly Improved Efficacy and Safety
“In the Sol-Gel kits, the proprietary silica microcapsules encase and continuously release the benzoyl peroxide, enabling a significant increase in efficacy and tolerance in comparison to products containing free benzoyl peroxide
As I said in July, many rosacea sufferers will know from their own experiences, many acne treatments are just too harsh for their sensitive rosacea skin.
If anyone sees some more information that confirms the makeup of DER45-EV please do let us know.
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November 6th, 2009, by Digital Davo | LED Therapy, patents
A newly filed patent contains a proposed rosacea treatment using small bands of infrared radiation between 790nm and 900nm with a power between 1 and 100 mW/cm^2. The unit proposed could be a LED device, used from twice a day to every 10 days. An energy density between 3 and 180 Joules/cm^2 is proposed.
Infrared Light is in the invisible spectrum below red, with wavelengths from 700nm to 2,000nm. We know that infrared light penetrates skin tissue more effectively than visible light.
An example device described is the OMNILUX Plus, which is promoted as “(Infra-red) works as a combination therapy with the Revive (red) head for even better skin rejuvenation, ideal for deeper lines and wrinkles”. OMNILUX Plus is based on a matrix of Infra Red LEDs, which provide narrowband 830nm light. This device is not currently promoted as a treatment for rosacea, so it seems that this patent covers using an existing treatment method for a new condition – rosacea.
The example treatment regime used an OMNILUX Plus unit at 830nm (+/- 0.5nm), using 55 mW/cm^2 at a distance of 1-10cm from the skin for 20 minutes with a power of 66 Joules/cm^2, twice a week for four weeks. Goggles were used and the unit was further placed 3-5cm from the patient’s nose.
The patent says that the patient enjoyed substantially reduced telangiectasia and reduced inflammatory papules.
Treating erythematotelangiectatic rosacea or papulopustular rosacea with narrow-band infrared light radiation and radiation kits therefor
United States Patent Application 20090270847, Lee; Seung Yoon, October 29, 2009
A method of treating erythematotelangiectatic rosacea or papulopustular rosacea in a subject comprises exposing the subject’s skin in need thereof to narrow-band infrared radiation at a wavelength(s) in a range of between 790 nm and 900 nm and having a band width of between 0 nm and 20 nm, in an effective dose to treat erythematotelangiectatic rosacea or papulopustular rosacea and essentially not to cause photothermolysis of the skin. Alternatively, a method of treating erythematotelangiectatic rosacea or papulopustular rosacea in a subject comprises exposing the subject’s skin in need thereof to narrow-band infrared radiation at a wavelength(s) in a range of between 790 nm and 900 nm and having a band width of between 0.1 nm and 20 nm, in an effective dose to treat erythematotelangiectatic rosacea or papulopustular rosacea. A kit for such methods comprises a radiation source generating narrow-band infrared radiation at a wavelength(s) in a range of between 790 nm and 900 nm, the narrow-band infrared radiation having a band width of between 0 nm and 20 nm and having a power density of between 1 mW/cm^2 and 100 mW/cm^2, and a manual instructing a user how to use the narrow-band infrared radiation for treating erythematotelangiectatic rosacea or papulopustular rosacea.
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