September 2nd, 2010, by David Pascoe | new treatments, red face
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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September 1st, 2010, by David Pascoe | clinical trials, new treatments, sansrosa
The recruiting manager from Frontage Clinical is looking for participants in the trial they are hosting for rosacea redness.
Frontage Clinical in Hackensack, NJ is conducting a research study to evaluate the safety of an investigational topical gel medication for moderate to severe facial redness associated with ROSACEA.
All qualified participants will receive at no cost evaluations by a certified physician, investigational gel medication and compensation for participating.
Must be 18 years or older and have been diagnosed with Rosacea.
Must contact Recruiting Department at (201) 678-0288 for further information
A reasonable guess is that this trial is for the Oxymetazoline based V-101 product from Vicept Therapeutics or the Phase II dose finding study for Sansrosa / CD07805/47. Perhaps there is some clue in that Sansrosa is called a gel and V-101 is called a cream, tipping me to guess that this the Sansrosa trial.
Regardless of the topical in question, I would expect that a lab involved in any trial will keep the product and client close to their chests in the interests of keeping blind tests blind.
If anyone is available then please do join the program so that a new treatment for the redness of rosacea can progress closer to possible availability.
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August 31st, 2010, by David Pascoe | makeup
I have been contacted by Mana Products to see if an volunteers are interested in a makeup session at the Soho, New York Studio. Please contact Adrienne if you are interested. It looks like their web site is www.manaproducts.com
We are working on a new cosmetic line of gentle, effective products to conceal rosacea and other skin flaws and create a flawless, natural-looking complexion. We are looking for women who might enjoy panel testing the products. If they qualify, they will be invited to visit our Soho, New York studio, where a professional makeup artist will apply the products and a photographer will take before and after photographs of them to be used in a how-to video and brochure. In return, they will be given a portable on-trend wardrobe of cosmetics to keep.
PLEASE NOTE: WE ARE SEEKING ORDINARY WOMEN OF ANY AGE, NOT PROFESSIONAL MODELS.
We ask that potential testers please email a photo of themselves and a daytime phone number where they can be reached.
Adrienne Penna
apenna AT manaproducts.com
Product Development
Mana Products Inc.
32-02 Queens Blvd.
Long Island City, NY 11101
718-361-2550 x 3326
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August 27th, 2010, by David Pascoe | seborrheic dermatitis
A formulation of Ketoconazole 2% for treating seborrheic dermatitis called Extina is currently being promoted by Stiefel Laboratories.
Stiefel, which is a part of GSK, is promoting Extina as the “first and only ketoconazole foam for scalp, body, and face” and being “proven for hair, there and everywhere”.
This foam-based formulation is potentially interesting because it is being promoted as approved for use on facial skin.
The formulation is described as a thermoliable hydroethanolic foam (also known as VersaFoam-HF). The prescribing information advises against dispensing the foam in your hands as it will being to `melt’ immediately. Instead, users are told to dispense the foam into the cap or another cold surface and use fingertips to gently massage into the affected area.
Officially, the reason that ketoconazole works when treating seborrheic dermatitis is unknown.
Active ingredients: ketoconazole
Inactive Ingredients: cetyl alcohol, citric acid, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) pro
See the Extina web site for the prescribing information and safety warnings.
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August 23rd, 2010, by David Pascoe | clinical trials, new treatments, red face
Hot on the trail of the Phase 1 Study Results and Funding Announcement is a listing confirming that Vicept Therapeutics are soon to start dose finding trials for the treatment of the redness of rosacea.
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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