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.

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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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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.

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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.

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Clinical Trial NCT00940992, A Dose-Range of DER 45-EV in Treatment of Rosacea (SGT-EBPO1-09)

To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

DER 45 EV Gel, 1%: Experimental, vs. Placebo Gel applied topically once a day for 12 weeks, vs. DER 45 EV Gel, 5% applied topically once a day for 12 weeks.

It isn’t clear if DER 45 EV is in fact benzoyl peroxide, this is just a guess based on the technologies being promoted by the company sponsoring this trial, Sol-Gel. The company’s technology is to use silica based microcapsules (cutely named Cool Pearls) that will allow a continual release of the active ingredient. Their Anti-Acne kit consists of a cleanser, toner, lotion and also spot treatment.

Sol-Gel Anti-Acne Clinical Study Shows Significantly Improved Efficacy and Safety

The results demonstrate that the company’s two strength Anti-Acne kits achieved pronounced efficacy and markedly improved tolerability.

…

“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,”

The marketing material for Sol-Gel Technologies gives the following description of the process behind creating their products – “Silicate materials are made by forming interconnections among colloidal nano-sized particles (the sol) under increasing viscosity, until a rigid mass is formed with about half the density of glass (the gel). Sol-Gel precisely engineers the process to fine-tune the size, structure and properties of the materials formed. The resulting drug delivery properties range from completely non-leachable to a selectively porous barrier that allows controlled release of active ingredients after the product is applied to the skin.”

The trial is listed to start in January 2010 so perhaps we will be able to find out more information before then.

This is a potentially interesting development, especially if this means that a harsh treatments such as benzoyl peroxide is tolerable by and beneficial to rosacea sufferers.

As many rosacea sufferers will know from their own experiences, many acne treatments are just too harsh for their sensitive rosacea skin.

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Calcium dobesilate (2,5-dihydroxybenzene sulfonate) is a vasoactive drug with presumed effects on endothelial integrity, capillary permeability and blood viscosity. It is often recommended for venous disorders, and also prescribed for diabetic retinopathy and other microvascular disorders.

rosacea and doxium (calcium dobesilate)

Just wanted to let others know that Dr. Cuevas accepted me as a participant in his clinical trial of the 2.5% Calcium dobesiliate cream. I had to arrange and pay for international shipping and managed to get the product into Canada (the product was described as a skin cream for customs purposes).

I have been using the skin cream for 2 weeks in the morning and evening. Redness has visibly decreased. My skin feels smooth and soft where there were small bumps previously. Spontaneous breakouts have also stopped. The study above was conducted over 4 weeks.

Anyone interested in participating in the clinical trial can submit photographs to Dr. Pedro Cuevas at:

pedro.cuevas@hrc.es

Dr. Pedro Cuevas
Servicio de Histología
Departamento de Investigación
Hospital Ramón y Cajal
Ctra. de Colmenar, km. 9.100
28034-Madrid-Spain

Tel. (0034) 913368290

Obviously rosacea sufferers have to be quite keen to pay for their own shipping, but it is only through research and trial and error that we will learn. Please do let us know if you too decide to try the calcium dobesilate cream.

The Clinical Trials register has listed a new trial for papulopustular rosacea. The trial, sponsored by Intendis, the manufacturer of Finacea, wants to compare the combination of Oracea and Finacea, with the combination of Oracea and Metrogel 1%.

It seems clear from this that Intendis would like to position Finacea as a viable alternative to Metrogel. This makes good sense when you consider that Metrogel was responsible for generating sales of about $75 million in 2004.

NCT00855595: Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-Inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-Inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea

Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycycline (40mg)daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.

Whilst sales of pharmaceuticals and thus returns to shareholders are a huge driving force in the big pharma market, this sort of venture is really just tinkering at the edges of rosacea research.

What we all long for, naturally, is real innovation. Real innovation costs big dollars too though, so in the end we do actually benefit from any increases in sales that these sorts of trials will hopefully lead to.

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Just posted on the clinicaltrials.gov database is an entry “Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea”. This topical product, known as Ziana, is currently approved for the treatment of acne.

Ziana is manufactured by Medicis who also make Plexion and Solodyn. The combination of tretinoin and clindamycin may be too harsh for some rosacea sufferers, so it will be interesting to see how the trial pans out. Ziana is marketed as the only topical to combine an antibiotic and a retinoid.

The trial will primarily measure a reduction in the count of papules and pustules from baseline to week 12. A secondary measurement will be transient redness. We can deduce from this that Ziana is only thought to be effective against the inflammatory lesions of rosacea, and will likely only have a mild effect on the redness.

Rosacea sufferers have many choices to treat papules and pustules, so sufferers may well be left wondering, why one more ? If you can’t tolerate metrogel, metrolotion, metrocream, noritate, topical clindamycin, finacea or plexion (just to name a few), then maybe, at a stretch, Ziana might offer you another viable option.

Have you tried Ziana for your rosacea ? How did you find it ?

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The Clinical Trial register is showing details for the bio-availabilty trial for COL-118/Sansrosa. This Phase 2 trial aims to compare the amount of the active ingredient that is bio-available when the newly formulated gel is used on rosacea skin, and when used as eye drops.

This announcement appears to be the extra trial asked for by the FDA who are concerned that rosacea skin may allow more systemic absorption than non rosacea skin. The side effects of Brimonidine when it gets into your blood are extremely dangerous. Even though the Phase 1 trials of COL-118 showed that healthy volunteers did not have measurable quantities of the active ingredient, diseased rosacea skin may allow more of the Brimonidine to enter the blood stream.

The bit that is new in this trial is that all of the participants will have moderate to severe erythematous rosacea and use the brimonidine ophthalmic solution. The group will be split randomly such that 1/2 will use the new Sansrosa Gel and 1/2 will use the inactive vehicle. The amount of the active ingredient in the blood plasma will be compared between the 2 groups. For the product to proceed to the next step, there will need to be no measurable difference.

The larger scale Phase 3 safety trials have been delayed until after this Phase 2 trial is completed in September this year.

From Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%

Primary Outcome Measures:
To assess the relative bioavailability of 0.18% COL-118 facial gel and 0.2% brimonidine ophthalmic solution under conditions of maximum use in patients with moderate to severe erythematous rosacea.

Secondary Outcome Measures:
To evaluate the safety of COL-118 administered topically as a facial gel in male and female subjects with moderate to severe erythematous rosacea

…

Detailed Description:

A double-blind, randomized, 2-way crossover, safety, pharmacokinetic/-dynamic (PK/PD) study of 0.18% COL-118 facial gel and 0.2% brimonidine ophthalmic solution administered in male and female patients with moderate to severe erythematous rosacea.

Twenty male and female subjects with moderate to severe erythematous rosacea will be randomized into 2 groups of 10 subjects.

Each group will be randomized to receive 2 treatments (Treatments A and B, in Sequence 1: A/B or Sequence 2: B/A), as follows:

Treatment A: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after four hours;

Treatment B: One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically.

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