Joseph F. Fowler, M.D., Clinical Professor of Dermatology at the University of Louisville was the principal study investigator. A summary of these results was mentioned in October 2011 via a press release covered here: Sansrosa not Susceptible to Tolerance or Rebound

Whilst we aren’t told what the adverse events were that affected around 15% of participants, we are told that they were `mild and transient’. One of the aims of the just-completed Phase III trials was to verify that any Adverse Events were not more common in a larger population.

These poster sessions offer further confirmation of the suitability of Galderma’s in-development CD07805/47 Brimonidine Bartrate based gel for the red face of rosacea.

Poster reference number 4825

Once-daily topical brimonidine tartrate gel 0.5% is safe and efficacious in the treatment of moderate to severe persistent facial erythema associated with rosacea

American Academy of Dermatology 70th Annual Meeting, March 16–20, 2012, San Diego, California. Poster Abstracts, Supplement to JAAD, April 2012, Volume 66, Number 4.

Joseph Fowler Jr, MD, University of Louisville, Louisville, KY, United States; Angela Moore, MD, Arlington Center for Dermatology, Arlington, TX, United States; Kappa Meadows, MD, The Education & Research Foundation, Inc, Lynchburg, VA, United States; Kimberly Grande, MD, The Skin Wellness Center, Knoxville, TN, United States

Brimonidine tartrate (BT), a highly selective a2-adrenergic receptor agonist with vasoconstrictive activity, was previously shown to significantly reduce persistent facial erythema associated with rosacea when applied as a topical gel.

The safety and efficacy of BT gel in this indication was assessed in this multicenter, double-blind, randomized, vehicle controlled phase II study (4 weeks daily treatment/4 weeks follow-up).

Erythema severity was assessed using two 5-point scales (0 = clear to 4 = severe), Clinician’s Erythema Assessment (CEA), and Patient’s Self-Assessment (PSA).

Subjects (n = 269) with moderate to severe facial erythema of rosacea (CEA and PSA scores $3) were randomized to one of five groups: BT 0.5% once daily (QD), BT 0.18% QD or twice daily (BID), or vehicle QD or BID.

BT 0.5% QD had a significantly superior success profile (defined as a 2-grade improvement profile on both CEA and PSA over 12 hours) compared to vehicle QD on day 29 (primary endpoint, P<.001), and on days 1 and 15 (both P<.001).

Success rates at hours 3, 6, 9, and 12 on day 29 were 30.2%, 28.3%, 32.1%, and 18.9%, respectively, for BT 0.5% QD, compared to 3.6%, 7.3%, 3.6%, and 3.6% for vehicle QD.

Results from the primary analyses were confirmed by the secondary analyses. BT 0.18% BID and QD were more efficacious than the vehicle BID and QD, respectively, although the differences were not always statistically significant.

No evidence of tachyphylaxis, rebound, or aggravation of other disease signs (telangiectasias, inflammatory lesions) was observed for any active treatment group.

Similar incidences of related adverse events (AEs) were reported for the active groups (11.1-18.9%) and the vehicle QD group (14.5%). Most related AEs were mild and transient.

In conclusion, BT gel 0.5% is safe and efficacious for the daily treatment of moderate to severe facial erythema associated with rosacea.

Fowler, Moore, Meadows and Grande all list financial relationships with Galderma in the Author Disclosures Appendix.

Poster reference number 4764

A single application of brimonidine tartrate gel significantly reduces moderate to severe facial erythema associated with rosacea

Kappa Meadows, MD, The Education & Research Foundation, Inc, Lynchburg, VA, United States; Andrew Pollack, MD, Philadelphia Institute of Dermatology, Fort Washington, PA, United States; Michael Jarratt, MD, DermResearch, Inc, Austin, TX, United States; Terry Jones, MD, J & S Studies, Bryan, TX, United States

Brimonidine tartrate (BT), a highly selective a2-adrenergic receptor agonist, was originally approved for the treatment of glaucoma. Due to its vasoconstrictive activity, BT was hypothesized to have the ability to reduce persistent cutaneous facial erythema associated with rosacea.

Since there are currently no pharmaceutical agents approved for this treatment indication, the effect of topical BT gel on the facial erythema of rosacea was evaluated in this double-blind, randomized, vehicle controlled, dose-finding study.

Erythema severity was assessed using two 5-point scales, Clinician’s Erythema Assessment (CEA) and Patient’s Self-Assessment (PSA).

Subjects (n = 122) with moderate to severe facial erythema from rosacea (CEA and PSA scores >3) were randomized to receive a single facial application of BT gel 0.07%, 0.18%, 0.5%, or vehicle.

A single application of topical BT gel was shown to significantly reduce facial erythema. The effect was superior to vehicle and consistently dose-dependent, with the highest concentration (0.5%) having the greatest strength and duration of effect.

The response rate for a 2-grade improvement on both CEA and PSA was 25.0%, 32.3%, and 54.8% for BT gel 0.07%, 0.18%, and 0.5%, respectively, compared to 12.5% for vehicle.

The median duration of effect after a single application of BT gel 0.5% was 11.53 hours (1-grade of improvement on CEA), 7.00 hours (2-grade of improvement on CEA), and 5.98 hours (2-grade of improvement on both CEA and PSA).

All tested BT gel concentrations were safe and well-tolerated. The incidence of subjects with related adverse events (AEs) ranged from 6.5% (2 subjects) with BT gel 0.5% to 14.3% (4 subjects) with BT gel 0.07%.

Most related AEs were transient, dermatological in nature, and mild in intensity.

In summary, topical BT gel significantly reduces facial erythema associated with rosacea in a dose-dependent fashion, with BT gel 0.5% providing superior strength and duration of effect.

Commercial support: Galderma Laboratories, L.P.

Meadows, Pollack, Jarratt and Jones all list financial relationships with Galderma in the Author Disclosures Appendix.

Related Articles

• Sansrosa not Susceptible to Tolerance or Rebound
• Sansrosa Completes Phase III Trials

These latest large scale trials were able to confirm the positive findings resulting from the Phase II trials.

This must be a great relief to Galderma who had to return to Phase II trials after previously commencing Phase III trials.

March 16, 2012 08:00 ET

Galderma Announces Completion of Phase 3 Trials of Investigational Drug Targeting Facial Erythema of Rosacea

FORT WORTH, TX–(Marketwire – Mar 16, 2012) – Galderma Laboratories, L.P. today announced the completion of two independent Phase 3 clinical trials that evaluated the efficacy and safety of CD07805/47, a proprietary topical gel under investigation in adults with moderate to severe facial erythema (redness) of rosacea. Rosacea is a chronic, inflammatory and vascular condition of the face and eyes characterized by persistent erythema, flushing, inflammatory lesions and visible blood vessels that affects at least 16 million Americans and with estimates of prevalence ranging from less than 1% to more than 20% of the adult population in other countries globally.

The results of the two randomized, vehicle-controlled, multicenter Phase 3 trials that investigated the efficacy and safety of CD07805/47 applied topically once daily vs. vehicle (control) in adult patients with moderate to severe facial erythema of rosacea confirmed results observed in prior Phase 2 studies.

…

Galderma intends to submit a New Drug Application for CD07805/47 to the U.S. Food & Drug Administration and to the European Medicines Agency.

When Will Sansrosa Be Available?

Best answer: No ones knows. There are just too many things still to be decided. It may never even get to market. My guess at the earliest you might see Sansrosa available is mid 2014. I reserve the right to push this date out at any time and please note that mid 2014 is still a pretty hopeful date.

Related Articles

• Final FDA Approval of Sansrosa, expect 15 months post Phase III
• Sansrosa not Susceptible to Tolerance or Rebound
• Sansrosa ingredients revealed in patent application
• Sansrosa delayed, sufferers make their own Brimonidine, BEWARE

The Daily Mail continues its interest in rosacea treatments with an article about an unnamed glaucoma treatment that has been formulated as a gel treatment for the redness of rosacea.

Of course we know this treatment as Sansrosa. Other names we have seen over the years include COL-118 and CD07805/47. The active ingredient in the glaucoma treatment of mentioned is Brimonidine Tartrate.

Gel that stops you from getting a red face in middle age

By PAT HAGAN

Last updated at 9:44 PM on 12th December 2011

A new gel could help banish the redness suffered by people with the skin condition.

The gel contains a drug widely used in eye drops to treat glaucoma, the disease that can cause blindness, which works by constricting blood vessels.

When used in the eye, the drug makes blood vessels shrink and reduces pressure that can cause vision problems.

Now researchers have reformulated it into a gel that can make blood vessels in the surface of skin contract, reducing the red and flushed appearance that many rosacea sufferers endure.

Scientists at the University of Louisville, Kentucky, used the new gel on 122 rosacea sufferers once or twice a day for four weeks.

Within 12 hours, there was an improvement in redness, according to results published in the British Journal of Dermatology.

The journal item mentioned in this article is detailed here: Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment of moderate to severe facial erythema of rosacea: results of two multicenter, randomized and vehicle-controlled studies

Related Articles

• Final FDA Approval of Sansrosa, expect 15 months post Phase III
• Sansrosa not Susceptible to Tolerance or Rebound

Some news today from the Phase 2B Sansrosa Trials;

Galderma is now confirming that during the 8 week trial, participants did not suffer from tachyphylaxis or rebound.

This means that if you stop and start sanrosa or continue to use it for an extended period you likely won’t suffer from a rebound effect or from a reduced effectiveness.

This is some good news as it indicates the formulation remains effective and safe for periods of around 4-8 weeks.

The trial news announced today does not relate to the on going Phase 3 Sansrosa trials.

The trials mentioned in today’s press release were first highlighted in August 2010 – Galderma sends Sansrosa backwards – Phase 2 Dosage Trials Again

PRESS RELEASE Oct. 20, 2011, 2:30 a.m. ED

Galderma Announces Positive Phase 2b Results for Investigational Compound Targeting Redness of Rosacea

LAUSANNE, SWITZERLAND, Oct 20, 2011 (MARKETWIRE via COMTEX)

Galderma Pharma, S.A., today announced positive top-line results from a Phase 2b trial that evaluated the efficacy and safety of CD07805/47, a proprietary topical gel under investigation for treating patients with moderate to severe facial erythema (redness) of rosacea. Rosacea is a chronic dermatological condition of the face and eyes characterized by persistent redness, flushing, inflammatory lesions and visible blood vessels that affects at least 16 million Americans.

“Currently, there are no medical therapies with FDA approval to treat the persistent facial redness of rosacea,” said Joseph F. Fowler, M.D., Clinical Professor of Dermatology at the University of Louisville and a principal study investigator. “The results of this study confirm CD07805/47′s potential to become a viable topical treatment option that could possibly help enhance the quality of life for the millions of patients affected by the persistent facial redness of rosacea.”

In the trial, CD07805/47 was shown to be rapidly effective at reducing facial redness. During the treatment and follow-up phases through the eight-week study, CD07805/47 was evaluated as safe and well-tolerated. There was no evidence of tachyphylaxis, or rebound, in the study.

The results will be submitted for publication where further data and analysis will be provided.

Phase 3 studies are currently ongoing.

Update: Journal Article Publised

The Sansrosa/Brimonidine tartrate (BT) Phase II trial data has also been written up as a Br J Dermatol article. The press release quoted above was a preview of this formal writeup of the Phase II Trials.

We can see that Galderma is working towards recommending the Sansrosa dosage of a 0.5% Gel used once per day.

Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment of moderate to severe facial erythema of rosacea: results of two multicenter, randomized and vehicle-controlled studies

Br J Dermatol. 2011 Nov 2., Fowler J, Jarratt M, Moore A, Meadows K, Pollack A, Steinhoff M, Liu Y, Leoni M; on behalf of the Brimonidine Phase II study group.

University of Louisville, Louisville, KY, USA DermResearch, Inc., Austin, TX, USA Arlington Center for Dermatology, Arlington, TX, USA The Education & Research Foundation, Inc., Lynchburg, VA, USA Philadelphia Institute of Dermatology, Fort Washington, PA, USA University of California at San Francisco, San Francisco, CA, USA Galderma R&D, Princeton, NJ, USA.

Background: Erythema of rosacea is thought to result from abnormal cutaneous vasomotor activity.

Brimonidine tartrate (BT) is a highly selective α(2) -adrenergic receptor agonist with vasoconstrictive activity.

Objective: To determine the optimal concentration and dose regimen of topical BT gel for the treatment of erythema of rosacea and to evaluate its efficacy and safety.

Methods: In Study A, 122 subjects were randomized to receive a single application of BT 0.07%, 0.18%, 0.5% and vehicle.

In Study B (4-week treatment and 4-week follow-up), 269 subjects were randomized to receive BT 0.5% once-daily (QD), BT 0.18% QD, vehicle QD, BT 0.18% twice-daily (BID) or vehicle BID. Evaluations included Clinician’s Erythema Assessment (CEA), Patient’s Self Assessment (PSA), chromameter measurements and adverse events.

Results: Study A – A single application of topical BT gel reduced facial erythema in a dose-dependent fashion. Significant difference between BT 0.5% and vehicle in chromameter redness value was observed from 30 minutes to 12 hours after application.

Study B – BT 0.5% QD had a statistically superior success profile (defined as 2-grade improvement on both CEA and PSA over 12 hours) compared to vehicle QD on Days 1, 15 and 29 (all P<.001). No tachyphylaxis, rebound of erythema or aggravation of other disease signs (telangiectasia, inflammatory lesions) was observed. All regimens were safe and well-tolerated with similarly low incidence of adverse events.

Conclusions: Once-daily BT gel 0.5% is well-tolerated and provides significantly greater efficacy than vehicle gel for the treatment of moderate to severe erythema of rosacea.

When Will Sansrosa Be Available?

Best answer: No ones knows. There are just too many things still to be decided. It may never even get to market. My guess at the earliest you might see Sansrosa available is mid 2014. I reserve the right to push this date out at any time and please note that mid 2014 is still a pretty hopeful date.

Related Articles

• Final FDA Approval of Sansrosa, expect 15 months post Phase III
• Sansrosa starts Phase 3 Trials (again)
• Sansrosa ingredients revealed in patent application

Given that we believe that the process is in the later stages of Phase III, what sort of best outcome possible, educated guess might be worth offering up?

Once the Phase III process completes (which itself averages 3.5 years) the final FDA approval of a New Drug on average takes around 15 months. This puts a dose of reality for those following drugs like Sansrosa or even further out, V-101.

Our current best guess for completion of Phase III trials for Sansrosa is around August 2012. So even if Galderma are ready to file the 100,000 pages of a New Drug Application at the end of 2012, then don’t expect any approval before the middle of 2014 at the earliest.

Sobering for those waiting.

Mid 2014 is Still Hopeful

There is currently no firm reason to believe that the Phase III trials will successfully complete at the end of 2012, but assuming the best case, for the sake of making an argument, the FDA approval process itself adds another one and half years.

Biopharmaceutical Research Companies Are Developing Nearly 300 Medicines to Treat Diseases of the Skin

New Drug Application (NDA)/Biologic License Application (BLA). Following the completion of all three phases of clinical trials, a company analyzes all of the data and files an NDA or BLA with FDA if the data successfully demonstrate both safety and effectiveness. The applications contain all of the scientific information that the company has gathered.

Applications typically run 100,000 pages or more.

The average review time for the 21 new therapeutics approved by the FDA in 2010 was 14.8 months.

Just one final note of caution: also be sure to factor in Galderma’s own timings and decisions as well. Galderma may possibly decide themselves that the drug isn’t suitable to become a product and halt the development at any time.

Related Articles

• Sansrosa starts Phase 3 Trials (again)

This just announced trial is shorter than the Long Term (52 week) Safety Trial, and seeks to confirm that Sansrosa Gel (CD07805/47) is more effective than the inactive vehicle gel and is itself a safe treatment.

Trial ID: NCT01355458 (seems to be somewhat duplicated with NCT01355471)

Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea.

The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.

• Estimated Enrolment: 260
• Study Start Date: May 2011
• Estimated Study Completion Date: November 2011
• Estimated Primary Completion Date: October 2011

By comparison the Long Term Trial for Sansrosa lists 450 participants and is use to be complete in August 2012.

How is “Effective” Measured?

This trial will measure success as 1-grade improvement in redness after 30 minutes and a 2-grade improvement in facial redness at Day 29. The improvement is based on the assessment by both the clinician and the patient.

Exclusions

Interestingly if you have 3 or more facial lesions (i.e. a rosacea papule or pustule) you are ineligible for this trial.

Related Articles

• Sansrosa composition revealed in patent application
• Galderma sends Sansrosa backwards – Phase 2 Dosage Trials Again
• Sansrosa delayed, sufferers make their own Brimonidine, BEWARE

News today that Galderma has listed CD07805/47 as entering large scale Phase III trials. Under the previous owners of the Brimonidine-based technology Collagenex, the product then known as Sansrosa was previously slated to commence Phase 3 Trials at the end of 2008.

The last news we heard about this product was in August last year when Galderma announced that they were restarting Phase II trials to examine the optimum dosage of the active ingredient. The Phase III trials have now chosen a concentration of 0.5% for the product moving forward.

We have no information about what caused Galderma to send the development of Sansrosa backwards, but it is encouraging to see the product finally moving forward again.

Why So Slow?

Reinforcing how slowly a new drug moves through the development pipeline are the dates for this study. This study just announced today won’t complete until August 2012. Naturally if you want to claim that a drug is safe to use for a year, you need to trial it for at least that period.

Experimenters Beware

Given that the one possible listing of ingredients of this product are known, you may be tempted to try it on your own. Please be careful, feedback from adhoc experiments is not positive with many reporting bad reactions including rebound redness.

Trial Details

Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Drug: CD07805/47 gel 0.5%

To evaluate and document the long term efficacy & safety of CD07805/47 gel 0.5% in subjects with moderate to severe facial erythema associated with rosacea.

Estimated Enrolment: 450

Study Start Date: March 2011

Estimated Study Completion Date: August 2012

Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Related Articles

• Sansrosa composition revealed in patent application
• Galderma sends Sansrosa backwards – Phase 2 Dosage Trials Again
• Sansrosa delayed, sufferers make their own Brimonidine, BEWARE

The path from the laboratory for Sansrosa / COL-118 / CD07805/47 to a product that realises the promise of permanently reducing  a red face has been a long one. We first heard about a product to become known as Sansrosa in Jan 2005 (also via a patent application in 2004).

Since then we have discovered that COL-118 was based on the active Brimonidine, as for example found in Alphagan-P from Allergan. Alphagan-P is used to treat the eye disease glaucoma.

Galderma purchased Collagenex in February 2008. Ever since Galderma took over the products of Collagenex, the development of Sansrosa has only headed in one direction – backwards.

Faced with the prospect of having to wait several more years, or worse, that the product will never reach market, rosacea sufferers are going it alone and making their own formulations of Brimonidine. This task was made all the more easier by the publishing of the Sansrosa Ingredients.

Using Prescription Drug Off Label

It is estimated that 1 in 5 prescriptions in US is for a use not approved by the FDA.

The availability of what looks like the ingredients listing for Sansrosa, and the encouragement of some doctors to look for off-label treatments is all that some sufferers require to experiment for themselves.

Using prescription drugs off-label is not illegal, but their use is  not regulated by the FDA.

Here are some good reasons that you should be careful with off label drugs;

• the bad reaction profile of the drug is not yet understood
• the final dosage and frequency of treatment information is not known
• you may not get insurance coverage for off-label usage
• the full safety profile of a drug might not be know until several years after it has become available.

Encouragement by Doctors

Some doctors, looking for new options to treat their patients, may even suggest using existing treatments off-label. Here Dr. Webster is encouraging the use of topical brimonidine for cutaneous flushing.

Eye and Nasal Drugs Tame Rosacea

“For patients who are having a big problem with flushing [or] blushing, brimonidine [Alphagan] is a great drug. I use it routinely in my office,” Dr. Guy F. Webster said at the annual Hawaii Dermatology Seminar sponsored by the Skin Disease Education Foundation.

“I prescribe the 0.15% concentration and tell patients to put a couple of drops on their fingers, rub it onto their cheeks, see how long the effects last, and then use it accordingly. Typically, you can get through a workday with one application,” according to Dr. Webster of Jefferson Medical College, Philadelphia.

“The redness will go away for a few hours. It’s a pretty darn good drug and seemingly safe,” he commented.

About 15 years ago, there were reports of a big rebound effect following chronic use of nasal decongestants for their indicated purpose. That doesn’t seem to be a problem when oxymetazoline is applied to the skin, in Dr. Webster’s experience, and as also borne out in a published detailed case report by another dermatologist (Arch. Dermatol. 2007;143:1369-71).

Dr. Webster said he likes brimonidine because it’s his clinical impression that the drug not only relieves the flushing and redness of rosacea, but it also improves the fixed telangiectasias that are often present. Oxymetazoline does not have that effect.

…

Dr. Webster disclosed that he serves as a consultant to or has other financial relationships with a number of pharmaceutical companies, including Allergan Inc., which markets brimonidine.

So, there are clinical trials underway, the drug is reasonably well understood and some doctors are happy to prescribe Brimonidine for off-label use.

What could possibly go wrong?

Make Your Own Sansrosa

The user WrinkledClue at the Rosacea Forum has been trying Brimonidine under the supervision of their V Beam doctor.

Following are some extracts from the thread that details WrinkledClue’s trials with Brimonidine.

16th July 2010 10:30 PM

So far, the Brimonidine blanches out the wretched, chronically flushing diseased cheek, and keeps it pale for about 30 hours. One drop does that. It’s amazing. No dermatological irritation. No rebound flushing when I test it by stopping. I’m hoping this may be the help I need to get through menopause until my body quits inflicting these horrendous hormonal storms of change upon my damaged face.

16th July 2010 10:47 PM

Forgot to add that I asked Dr Masters about rebound flushing from Brimonidine. He said that nasal sprays cause rebound flushing when used in the nose. But his research indicates that Brimonidine, (a glaucoma drug, NOT a nasal spray), does NOT cause rebound flushing when used off label, topically, on a rosacea face. And that’s been my experience, too — no rebound effect. My rosacea breaks through everything I throw at it. If this stuff works well, it’ll be a godsend and I will highly recommend it.

19th July 2010 08:54 PM

This prescription eye drop for glaucoma called Brimonidine is really helping my wretched face. But I wanted to caution you NOT to put it directly on your face. It’s too strong. If you put it directly on your face, you’ll get a weird looking blanched-out circle that will get white within an hour or two and stay white for about 24 – 30 hours. Instead, you have to dilute the Brimonidine with a cream or moisturizer.
I put a dollop of Finacea in one palm, add a drop of water, and then add ONE DROP of Brimonidine to it. Stir with a finger and use that to paint half my face. Repeat on the other half of my face. Results after about one week of use, so far, are simply spectacular. And I’m hard to impress, with severe, progressive, debilitating flushes.

3rd August 2010 09:24 PM

The Brimonidine is still surpassing my expectations, and much of the permanent redness seems to be slowly leaving.
Also the Brimonidine seems to be slowly shrinking my spider veins and fixed telangectasias, yes. Good stuff, this new drug! -WC

Natalja posted some pictures from her Trial of Brimonidine at Vascular Rosacea Experiences of a Patient2

4th September 2010 12:47 PM (Melissa W)

Hi Natalja, I’m so sorry it caused rebound flushing for you. It did the same for me when I tried alphagan drops on my face in January 2009. When I tried this med though I used the .1 and then the .15% concentration so it was weaker than what you and WC and the others are using I believe. I don’t know why for some people it causes this reaction and for some it does not. The real question is why it isn’t causing the rebound for the others. Hopefully that is something the scientists are working on regarding this and perhaps that is why it is taking so long to come to market.

15th September 2010 10:22 PM

I do wonder why some folks are getting horrific rebound flushing. It certainly takes away from the wonder of this vasoconstrictor.
Let me repeat that I am using very small amounts of the Brimonidine. I literally add NO MORE THAN two or three drops from the tiny bottle to a rather large dollop of finacea; I add a few drops of water to that, I stir it all around with my finger, and then I use that to paint my entire face. It does seem like a little Brimonidine goes a very long way. I’ve noticed that Finacea is fabulous for my rosacea, I wonder if that’s making the difference? Some of the folks with rebound flushing are diluting the Brimonidine only with water and putting that directly on their face. That’s not what I do. Hoping for better health for all of us. –WC

19th November 2010 08:18 PM

Well, it’s taken four months, but now I too am getting rebound flushing from the Brimonidine. Maybe it took so long because I was using such a tiny amount? Brimonidine’s great when it’s working, but when it wears off, I’m redder than I was before putting it on. Which is awful. I’m so disappointed. I was heartbroken when so many others had bad results with it, and now I’m having bad results with it too.
Such a shame. More hope, dashed.

20th November 2010 03:35 AM

Hello Mistica, I quit the Brimonidine cold turkey. I used low dose hydrocortisone over-the-counter for two days to deal with the rebound flushing. Then I quit that, too. Now I’m all recovered from my Brimonidine experiment. Amazingly, I’m getting better, too– maybe the result of all the heavy V Beams I’ve had in the last year. Hoping for better health for all of us.

Wrapping Up The Trial

I put some questions to WC now that their trial of Brimonidine concluded.

Q: How did you go about finding out whether this treatment might be an option for you ?

A: I found out about Brimonidine when my dermatologist recommended it for me.

Q: Did using a treatment off label worry you?

A: Nothing about it worried me.   I figured I could always just stop if I had a bad reaction.

Q: Would you have any advice for others in your situation?

A: Use it sparingly.   I didn’t have rebound flushing for something like four months because I was only using a drop or two on my entire face.   People who had bad rebound flushing right away really used quite a lot of it.

Brimonidine Unsuitable ?

I hope that Galderma has solved the rebound problem with their final formulation of CD07805/47 because Brimonidine appears to be unsuitable topically on rosacea skin.

Many users are reporting strong rebound redness and flushing from Brimonidine. Please use Brimonidine, if at all, with care and under supervision of a doctor.

Worth The Risk ?

What do you think ? How experimental are you willing to be to find relief ? Is the absence of FDA approval enough to warn you off treatments like this ?

Alternatively, how do you decide for yourself where to draw the line when considering your own treatments ?

Related Articles

• Sansrosa ingredients revealed in patent application
• Sansrosa gel vs. eyes drops absorption trial details posted
• Galderma sends Sansrosa backwards – Phase 2 Dosage Trials Again

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.

This latest trial will compare Sansrosa, or CD07805/47 as Galderma now calls it, in strengths of 0.5% and 0.18% against a placebo containing just the vehicle gel. A total of 260 patients will be studied with an estimated primary completion date of February 2011.

Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Estimated Enrollment: 260

Study Start Date: August 2010

Estimated Study Completion Date: March 2011

Estimated Primary Completion Date: February 2011

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

This trial is in addition to the September 2009 trial covered by Rosacea News as Sansrosa starts Phase II strength tests, still a long way to go. That earlier dose-finding trial compared topical gel concentrations of 0.07%, 0.18% and 0.50% and involved 112 participants.

One could speculate from this just listed trial that Galderma is not impressed with the efficacy of CD07805/47 Gel at 0.07%.

It is well worth noting that Sansrosa is now firmly fixed back in Phase 2 trials, and the all important much larger Phase III trials cannot even be contemplated until at least the middle of 2011.

Since Galderma acquired Collagenex in February 2008, Sansrosa has only headed backwards in its development cycle. Galderma don’t seem to be in any rush to get this product to market. This is surprising as there is such a dearth of treatments for the redness of rosacea.

In June 2008 Collagenex tested topical Sansrosa 0.18% against Bromidine Ophthalmic 0.2% to compare systemic absorption of the active molecule.

Previous Phase 2 dose-finding trials by Collagenex, for COL-118, as they then called it, were made public as far back as August 2007  (see Sanrosa (COL-118) phase 2 looking promising).

Here we are 3 years later, and yet again this product is undergoing trials to determine the percentage of active ingredient that should be further developed.

Whilst it may be easy for those waiting for this product to become discouraged, it is a positive that we at least know that Galderma have the R&D dollars to see this product through. Of course this is itself predicated on Galderma continuing to believe that Sansrosa will become a viable product and make substantive returns for their shareholders.

Sansrosa; the never ending story.

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