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.

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.

Related Links

• Vicept Therapeutics positive Phase I study of V-101 for redness of Rosacea
• Vicept Therapeutics gets funding for V-101
• Sansrosa’s sister to enter redness race
• oxymetazoline good for 6 hours and safe for 3 months
• oxymetazoline may be good for 2 years
• AAD Poster Sessions: oxymetazoline
• 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.”

Related Articles

• Vicept Therapeutics gets funding for V-101
• Sansrosa’s sister to enter redness race
• oxymetazoline good for 6 hours and safe for 3 months
• oxymetazoline may be good for 2 years
• AAD Poster Sessions: oxymetazoline
• patents abound for treating rosacea with alpha agonist

Minocycline, as one of the tetracycline family may also offer some anti-inflammatory benefit to rosacea sufferers, but the question remains as to whether this benefit can be seen as a topical applicaiton.

Foamix are proposing to trial their foam technology with minocycline as a rosacea treatment.

Topical treatments need to penetrate the skin to access the cells that the active molecules target. Perhaps this form of application might provide an alternative method to relieve the inflammation associated with rosacea.

Certainly in order to show that foaming topical minocycline is a winner, Foamix will need to show that it is at least as effective as and indeed offer some benefit over metronidazole and azelaic acid.

Foamix promote the ease of application and the absence of alcohol in their products, suggesting that it is ideal for many dermatological agents

Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients

This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.

A Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study. The study will involve three treatment groups. Eligible patients will be randomized to receive either FXFM244 – 1%, FXFM244 – 4% or Placebo, in a blinded fashion. Patients will be treated twice daily for 12 weeks. Following the screening period and baseline visit, study subjects will return at Weeks 3, 6 and 12. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.

The trial will examine topical minocycline foam at strengths of 1% and 4% over a period of 12 weeks.

Related Articles

• minocycline reduces eyelid bacteria
• how do tetracyclines help rosacea ?
• RSRP: Minocycline

The Clinical Trials Register is listing a new trial today for a topical retinoid, Atralin Gel 0.05% for the treatment of the redness and broken blood vessels of rosacea. Officially the trial will look at the redness, telangiectasia, facial edema, and dry skin of around 80 rosacea sufferers over a period of up to 46 weeks. Additionally the evaluation of flushing, burning, stinging, and topical product intolerance will be incorporated into the trial.

Atralin Gel is a topical retinoid indicated for the treatment of mild to moderate acne vulgaris. The trial description specifically mentions that the gel will be applied 3 times per week and only if no irritation is seen will the participant be instructed to increase the frequency of use to once per day.

The trial collaborator is Valeant Pharmaceuticals, who distribute Finacea in the US on behalf of Intendis. Valeant also makes the Kinerase, CeraVe and Dermaveen range of products.

Atralin Gel for the Treatment of Rosacea

Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).

The trial lists the following papers as being relevant to the use of topical retinoids for rosacea;

• Retinaldehyde alleviates rosacea Dermatology 1999;199 Suppl 1:53-6.
• A comparison of the efficacy of topical tretinoin and low-dose oral isotretinoin in rosacea Arch Dermatol. 1994 Mar;130(3):319-24
• Rosacea: II. Therapy J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4

Related Articles

• Product Page: Atralin Gel
• Isotretinoin – Rosacea Support Group: Supplements & Resources
• focus on low-dose accutane
• dramatic results with low dose accutane

The Clinical Research Unit is seeking men and women, at least 18 years old, to participate in a research study of a new oral investigational treatment for Rosacea.

The study requires 10 visits over 16 weeks.

Participants may be eligible to receive:

• Free facial skin examinations
• Free medication
• Compensation of up to $250

Contact:

• Department of Dermatology Clinical Research Unit
• Telephone:  212-305-6953

Email:  cc2241@columbia.edu

Apremilast (CC-10004) has been trialled for use in psoriasis and psoriatic arthritis. It would seem that Celgene are now interested in seeing if Apremilast is useful for treating another inflammatory skin condition such as rosacea.

Open Label Pilot Study of Apremilast in Treatment of Rosacea

An Open Label, Pilot Study to Determine the Efficacy of Apremilast in the Treatment of Rosacea in Patients With Both Erythematotelangiectatic Rosacea and Papulopustular Rosacea

This is a single-center, open label trial of Apremilast in ten (10) subjects with moderate to severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12 weeks. Following the screening period and baseline visit, study subjects will return at weeks 1, 2, 4, 6, 8, 10 and 12. There is a follow up study visit at week 16.

Recent research has shown an increase of specific proinflammatory cytokines in the biopsies of inflammatory lesions from rosacea and acne patients. The cytokines then trigger a chain of chemical responses in the body that likely result in the development of the papules an pustules that are seen in rosacea and acne patients. Apremilast is an oral agent that modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with potential therapeutic benefit for treating inflammatory autoimmune disorders.

We therefore propose a pilot study to evaluate the potential for Apremilast to improve the signs and symptoms of moderate to severe inflammatory rosacea.

Note that the list of inclusion and exclusion is long and slightly scary looking. Celgene are obviously quite concerned about unintended side effects of their new drugs.

Related Articles

• Celgene: Anti-Inflammatory Compounds

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.

Related Articles

• Solaraze (diclofenac sodium topical gel) being studied
• metronidazole (metrogel, flagyl) popular rosacea treatment
• generic metrogel soon – Fougera

Zoe Draelos MD is listed as a contact for the trial. Dr. Draelos is well known to rosacea sufferers. You can read some more of her research via the popular Rosacea News items: cleansing and the management of rosacea, finacea is good for acne and hyper pigmentation as well, and cetaphil gentle skin cleanser well tolerated.

Not a lot can be found on the internet about the company or the product mentioned in this trial. It seems that Topical Dissolved Oxygen has been trialled as a wound healing stimulant – an alternative to hyperbaric chamber therapy. If you have any more information, please post in the comments below.

The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage

This study is an evaluation of the role of topical dissolved oxygen to lessen visible signs of photodamage using a select regimen of topical dissolved oxygen containing cosmeceutical products. Evaluation of the overall skin tolerability of topical dissolved oxygen (safety) utilizing the regimen of products.

Related Items

• reapply sunscreen to avoid skin damage
• photo rejuvenation with IPL

Clinical Trial NCT00945373: Combination Therapy for the Treatment of Rosacea

The purpose of this study is to determine the efficacy of calcium dobesilate in combination with pulsed dye laser for the treatment of rosacea.

Drug: calcium dobesilate 2.5% gel

Procedure: pulsed dye laser

All study patients will be treated with 595 nm PDL (Vbeam, Candela Corp, Wayland, Mass) with an initial test spot using a fluence of 10 J/cm2, 7-mm spot size and 1.5-ms pulse duration. Based on the biologic response of the test area, the fluence will accordingly be adjusted up or down to find a fluence that produces a transient purpuric effect for a few seconds only.

Several studies have shown successful treatment of rosacea-associated telangiectasia and erythema with pulsed dye laser. Moreover, calcium dobesilate (2,5-dihydroxybenzene sulfonate) is a drug that inhibits vascular smooth muscle cell growth and inhibits cellular proliferation. As a synthetic inhibitor of fibroblast growth factor (FGF), calcium dobesilate targets angiogenic growth factors which lead to uncontrolled blood vessel growth. In light of the fact that angiogenesis has been implicated in erythematotelangietatic rosacea, calcium dobesilate will be useful in the treatment of this subtype of rosacea.

Thus, combination treatment with PDL and calcium dobsilate will act in a synergistic manner to reduce the erythema, flushing and telangectasia associated with erythematotelangietatic rosacea.

Related Articles

• rosacea and doxium (calcium dobesilate)
• Doxium (calcium dobesilate) trialists wanted
• pulse dye laser improves erythema
• pain, swelling and redness after pulse dye laser treatments
• pulsed dye laser and papulopustular rosacea