Dermatology Times today has an article that confirms some insights into the recent Phase II study into the safety and efficacy of different strengths of the Sansrosa Gel. The article adds some personal insights into the trial from the principal investigator, Dr. Joseph Fowler MD.

This is not the most recent news as Rosacea News highlighted some of these Phase II results back in March : Sansrosa Phase II Results at 2012 AAD San Diego

Note we also know some results from the Phase III Trials: Sansrosa Completes Phase III Trials

Key Findings

• Adverse events were around 11 to 19 percent of participants, but no patients left the trial because of bad effects.
• No aggravation of papules and pustules or telangiectasia was seen.
• No rebound redness or tachyphylaxis (a sudden reduction in effectiveness) was observed.
• Once a day treatment with the 0.5% formulation was more effective than 0.18% twice a day

Topical gel quells persistent erythema of rosacea

Publish date: Sep 1, 2012
By: John Jesitus

Louisville, Ky. — Once-daily application of Sansrosa (brimonidine tartrate/BT gel, Galderma) 0.5 percent has proven safe and effective for treating the persistent facial erythema of rosacea, according to the results of a phase 2 trial.

…

"The study’s most significant result was the striking improvement in redness — the treatment really works," says principal investigator Joseph Fowler, M.D. He is a Louisville, Ky., dermatologist in private practice, clinical professor of dermatology at the University of Louisville and assistant clinical professor in the Division of Occupational Medicine at the University of Kentucky.

…

Additionally, he says that it was somewhat surprising that the once-daily 0.5 percent concentration was much more effective than 0.18 percent used twice daily. "Going into the study, it was uncertain" which dose would prove optimal, he says. "Most dermatologists would prefer to have a once-daily product because patient compliance is a lot better."

Dr. Fowler surmises that the twice-daily BT 0.18 percent didn’t work as well as 0.5 percent QD because it takes a certain level of the drug to penetrate the stratum corneum and get into the skin. "Therefore, even if you apply a low concentration more frequently, you probably never get enough penetration" to achieve efficacy. At the lower concentration, "There was efficacy — it just wasn’t as good and as prolonged. That tells us the higher concentration is necessary to get the drug into the skin to do what it has to do," he explains.

Because the treatment has little residual effect, Dr. Fowler says, "Patients will need to use it on an ongoing basis to maintain the reduction in redness." To date, no published study has evaluated the treatment’s safety beyond four months, he says. "However, I don’t anticipate any issues. Patients with rosacea tend to have sensitive skin. To me, that would be the biggest concern, although we didn’t see much of that with this product.

When Will Sansrosa Be Available?

Dr. Fowler, who is a consultant for Galderma offers the prediction that “the product could reach the market in summer or fall 2013”.

This is quite optimistic it would seem as the New Drug Application for Sansrosa is still not confirmed to have been submitted.

My guess is that Sansrosa being available by mid  2014 is still on the hopeful side.

Dr. Fowler was not able to confirm how close Galderma is to being able to make the actual NDA submission to the FDA.

Related Articles

• Sansrosa Completes Phase III Trials
• Sansrosa not Susceptible to Tolerance or Rebound
• Combine Brimonidine and Oxymetazoline, Why Not?
• “Glaucoma Gel” Good for Redness: Daily Mail
• Sansrosa not Susceptible to Tolerance or Rebound
• Final FDA Approval of Sansrosa, expect 15 months post Phase III