A cne and rosacea are some of the most common conditions you treat everyday. And patients are always looking for better, faster treatments. Here, we’ll highlight some of the latest news and trends about the acne and rosacea prescription market and present details of new research about these conditions. A Slowly Growing Global Market The forecast for acne and rosacea drugs. In 2003, the global market for prescription acne and rosacea products reached revenues of $1.6 billion, a 0.2% increase from 1998, according to a report from Kalorama Information, a publishing division of MarketResearch.com. The report found that growth in general was reduced due to the patent expiration of the isotretinoin, Accutane, and new generic competition. For 2003, the largest growth in this market was seen in the retinoid segment with a 62% share of the total market. And while this is still the largest segment, again the patent expiration of Accutane in February 2002 led to a decline in market share. According to Kalorama, since the patent expiration, sales for Accutane have decreased by half in 2003. Growth for this acne and rosacea global market is forecast to reach revenues of $2.2 billion in 2008, which demonstrates a compound annual growth rate of 6.7% from 2003 to 2008. United States Sees Decline in Acne/Rosacea Market Negative growth seen from 1998 to 2003. While the global market has continued to grow, the U.S. market for prescription anti-acne and rosacea drugs reached $597.3 million in 2003, which was a 9.3% decrease from 1998. The patent expiration of Accutane, a retinoid, was a key factor in the decline in the U.S. market, but this was offset by the introduction of newer formulations of the tretinoin, Retin-A, and growth in other segments, which contributed to overall growth in the global market. The forecast for the U.S. acne and rosacea market is for growth. According to Kalorama Information research, the market will grow to $738.5 million in 2008, which reflects a 4.3% compound annual growth rate for 2003 to 2008. The growth forecast is attributed to the effectiveness of current products and to reasonable prices for products because of the increased generic competition. New products approvals will also add to the market. Safety and Efficacy of Combination Gel to Treat Acne Analysis of six controlled trials. Researchers evaluated the combined data analysis of six controlled European studies using the combination gel clindamycin phosphate 1%/tretinoin 0.025% (Velac Gel) versus either product alone in treating moderate to severe acne vulgaris. The safety and efficacy of the combination gel was investigated in six active-controlled, parallel group studies conducted by Yamanouchi Europe B.V. Data from the studies were then combined to provide an integrated analysis of safety and efficacy. J. Leyden, M.D., of the Hospital of the University of Pennsylvania, and A. Yaroshinsky, Ph.D., of Connetics Corporation, presented the findings in a poster at the Annual American Academy of Dermatology meeting in February. Males and females aged 14 to 26 with moderate to severe acne vulgaris (>3 Cook’s global assessment scale) were enrolled in the studies. Participants were given products to apply to the face once a day for 12 weeks and efficacy assessments included the percent change from baseline to week 12 in lesion count (inflammatory, non-inflammatory and total), and the proportion of patients with treatment success defined as a Cook’s Investigator’s Global Assessment score of clear or almost clear. Analysis of the studies showed that the combination gel was more effective in the treatment of acne than either product alone. (See the table below for more details.) It was also well-tolerated. New Treatments for a Common Side Effect of Isotretinoin The best ways to treat dry eye. Patients taking isotretinoin (Accutane, Amnesteem, Claravis, Sotret) regularly suffer from a dry eye condition, which can be extremely uncomfortable, and, if left untreated, can damage the tissues of the eye’s surface or the cornea of the eye, which can lead to vision loss. But before telling patients to discontinue their isotretinoin treatments, there are a number of ways to treat this condition and bring relief to your patients. Eric Donnenfeld, M.D., a Founding Partner of the Ophthalmic Consultants of Long Island in New York and Co-Chairman of Cornea and External Disease at Manhattan Eye and Ear Hospital in New York City, says that the first step in treating dry eye is to assess the damage with a supravital stain, such as lissamine green or rose bengal. It’s important to include patients in the decision for therapy for this condition. If the patient knows the risks of dry eye and is willing to try different treatments in order to stay on isotretinoin, there are many available treatments. But, says Dr. Donnenfeld, if damage to the central cornea, which can affect vision, is found, isotretinoin should be discontinued. First-line therapy is to treat the dry eyes with artificial tears, according to Dr. Donnenfeld, who recommends transiently preserved tears, such as Refresh, TheraTears and Genteal. Patients should be instructed to use the drops four times per day for as long as necessary. If the drops don’t help, the next step would be to add a viscous ointment gel at night, such as TheraTears Liquid Gel or Refresh Liquagel, or an ointment such as Refresh P.M. According to Dr. Donnenfeld, this line of therapy works on about 50% of patients in relieving dry eye symptoms. If the damage from dry eye is more advanced, Dr. Donnenfeld recommends cyclosporin ophthalmic emulsion (Restasis). This product is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation. Dr. Donnenfeld explains that this immunomodulator actually reverses dry eye and improves the quality of the patient’s own tears. Cyclosporin ophthalmic emulsion should be used twice a day and results are typically seen after 1 month of treatment. Counsel patients that one in seven patients may experience irritation when they first start with this treatment. Tacrolimus eye drops are also currently under FDA investigation as a treatment for dry eye. In the Pipeline Another treatment option on the horizon for dry eye is mucous-secreting agonists, which will allow patients to secrete more mucus to relieve dry eye symptoms. The FDA has recently granted priority review status to Inspire Pharmaceuticals Inc.’s application for the approval of diquafosol tetrasodium (INS365) as a topical medication for dry eye disease. Diquafosol is administered topically to stimulate fluid flux across the conjunctiva and to stimulate mucin release from goblet cells. Phase II and III clinical trials revealed that diquafosol was superior to placebo lubricant therapy in improving corneal surface staining and easing symptoms of foreign body sensation. The clinical trials also showed that the medication was well tolerated. Other Therapies Dr. Donnenfeld says that oral nutritional supplements that contain flaxseed oil and omega-3 fatty acids have also been shown to improve dry eye conditions by improving secretion of tears and tear film. He recommends patients take two ThearTears Nutrition pills two times per day. Editor’s Note: Dr. Donnenfeld is a consultant with Allergan, Alcon and Bausch and Lomb. He can be reached at eddoph@aol.com. Role of Bacteria in Rosacea News from the National Rosacea Society. A National Rosacea Society-funded study by Dr. Kevin Kavanagh and colleagues at the National University of Ireland, Maynooth, found a possible role for bacteria associated with microscopic mites in the development of subtype 2 (papulopustular) rosacea. The researchers found that the bacterium Bacillus oleronius stimulated an immune system response, including high levels of T-cell proliferation, in 79% of patients with subtype 2 rosacea, compared with 29% of patients without rosacea. This bacterium is found in Demodex folliculorum, which are normal inhabitants of human skin and are often found in much greater numbers in patients with rosacea. Dr. Kavanagh explained that there are many reasons why the Demodex and bacteria interact to cause inflammation in rosacea. One possibility is that the Demodex mites carry the bacteria to areas of the face susceptible to the changes of rosacea, resulting in higher density of bacteria that produce the papules and pustules of rosacea. Or, the mites may be attracted to skin with a lot of this bacteria. Another possibility is that the Demodex mites in rosacea patients are infected with the bacteria, which produce a stimulatory antigen that triggers the disorder in susceptible patients, according to Dr. Kavanagh. The researchers reported that the role of the bacteria in causing papulopustular rosacea is supported by the fact that initial typical treatment for rosacea includes oral antibiotics that destroy B. oleronius and that antibiotics that aren’t harmful to these bacterial are usually ineffective in treating rosacea. According to the National Rosacea Society, Dr. Kavanagh and the other researchers are now developing antibodies against the antigen produced by B. oleronius to confirm its presence on the faces of patients with papulopustular rosacea and to define its relationship with Demodex mites. Once-A-Day Gel Versus Twice-A-Day Solution A comparison of the efficacy and safety. A multi-center, investigator-masked, randomized, active and placebo-controlled, parallel group comparison was conducted to demonstrate similar efficacy and to assess safety of clindamycin gel 1% once a day versus clindamycin topical solution 1% twice a day. Investigators, M. Alirezai, B. Gerlach, A. Horvath, D. Forsea, P. Briantais and M. Guyomar, under sponsorship from Galderma, also looked at the gel versus its vehicle. Results were presented in a poster at the annual AAD meeting in February. Of the 592 patients enrolled in the study, 530 completed the study. Patients received clindamycin gel 1% (265 patients) once a day, clindamycin topical solution 1% (261 patients) twice a day or clindamycin gel vehicle (66 patients) once a day. Study products were applied to the face for 12 weeks, with evaluations at weeks 4, 8 and 12. The reduction in inflammatory lesion counts after 12 weeks of treatment was similar with 62.2% in the gel group and 65.3% in the solution group. The clindamycin gel 1% was found to be significantly superior to its vehicle (50.6%) after 12 weeks of treatment (p=0.006). The percent reduction from baseline in total lesion count at endpoint was not statistically significant between the gel (52.6%) and the topical solution (56.9%). However, the difference between the gel and its vehicle (43.6%) was statistically significant (p=0.009). In terms of safety, slightly less adverse events related to the treatment occurred in the gel group (6; 2.3%) compared to the topical solution group (9; 3.4%). The vehicle group only had one adverse event. Researchers concluded that the efficacy of the once-a-day water-based gel was equal to that of the twice-a-day topical solution, and the gel was significantly superior to its vehicle. All were safe. Comparing Benzoyl Peroxide Washes How effective are these products in fighting P. acnes? In order to evaluate the antibacterial efficacy of four formulations of benzoyl peroxide cleansers against Propionibacterium acnes, researchers from Stiefel Laboratories conducted an in vitro kill-rate study. Investigators, Patricia M. Savoie, Nadia Whitbeck and Joanee M. Fraser, Ph.D., tested four products that contained benzoyl peroxide at 3%, 4%, 4% and 5%, respectively, each in a different cleansing base. Each product was diluted 1:5 with TAT broth to which P. acnes were then added. Investigators then removed, neutralized and plated for incubation 1 g aliquots at 20-second, 1-minute and 5-minute intervals. Investigators looked at these time frames because the way people typically use washes or cleansers involves applying the product to their face and rinsing it off with water after waiting a few seconds or minutes. Colony forming units were also counted after 4 days of incubation at 32 to 35 degrees Celsius under anaerobic conditions. In this study, the 3% cleanser was not found to be effective in reducing P. acnes at the 1 to 5 dilution. The 4% cleansing lotion and the 5% wash were somewhat effective with log reductions of approximately 2. Lastly, the 4% creamy wash was found to be very effective with more than a 3 log reduction in P. acnes. It’s important to note that the comparative clinical effectiveness of these wash-off products was not tested in this study.
An Update on Acne and Rosacea Treatments
A cne and rosacea are some of the most common conditions you treat everyday. And patients are always looking for better, faster treatments. Here, we’ll highlight some of the latest news and trends about the acne and rosacea prescription market and present details of new research about these conditions. A Slowly Growing Global Market The forecast for acne and rosacea drugs. In 2003, the global market for prescription acne and rosacea products reached revenues of $1.6 billion, a 0.2% increase from 1998, according to a report from Kalorama Information, a publishing division of MarketResearch.com. The report found that growth in general was reduced due to the patent expiration of the isotretinoin, Accutane, and new generic competition. For 2003, the largest growth in this market was seen in the retinoid segment with a 62% share of the total market. And while this is still the largest segment, again the patent expiration of Accutane in February 2002 led to a decline in market share. According to Kalorama, since the patent expiration, sales for Accutane have decreased by half in 2003. Growth for this acne and rosacea global market is forecast to reach revenues of $2.2 billion in 2008, which demonstrates a compound annual growth rate of 6.7% from 2003 to 2008. United States Sees Decline in Acne/Rosacea Market Negative growth seen from 1998 to 2003. While the global market has continued to grow, the U.S. market for prescription anti-acne and rosacea drugs reached $597.3 million in 2003, which was a 9.3% decrease from 1998. The patent expiration of Accutane, a retinoid, was a key factor in the decline in the U.S. market, but this was offset by the introduction of newer formulations of the tretinoin, Retin-A, and growth in other segments, which contributed to overall growth in the global market. The forecast for the U.S. acne and rosacea market is for growth. According to Kalorama Information research, the market will grow to $738.5 million in 2008, which reflects a 4.3% compound annual growth rate for 2003 to 2008. The growth forecast is attributed to the effectiveness of current products and to reasonable prices for products because of the increased generic competition. New products approvals will also add to the market. Safety and Efficacy of Combination Gel to Treat Acne Analysis of six controlled trials. Researchers evaluated the combined data analysis of six controlled European studies using the combination gel clindamycin phosphate 1%/tretinoin 0.025% (Velac Gel) versus either product alone in treating moderate to severe acne vulgaris. The safety and efficacy of the combination gel was investigated in six active-controlled, parallel group studies conducted by Yamanouchi Europe B.V. Data from the studies were then combined to provide an integrated analysis of safety and efficacy. J. Leyden, M.D., of the Hospital of the University of Pennsylvania, and A. Yaroshinsky, Ph.D., of Connetics Corporation, presented the findings in a poster at the Annual American Academy of Dermatology meeting in February. Males and females aged 14 to 26 with moderate to severe acne vulgaris (>3 Cook’s global assessment scale) were enrolled in the studies. Participants were given products to apply to the face once a day for 12 weeks and efficacy assessments included the percent change from baseline to week 12 in lesion count (inflammatory, non-inflammatory and total), and the proportion of patients with treatment success defined as a Cook’s Investigator’s Global Assessment score of clear or almost clear. Analysis of the studies showed that the combination gel was more effective in the treatment of acne than either product alone. (See the table below for more details.) It was also well-tolerated. New Treatments for a Common Side Effect of Isotretinoin The best ways to treat dry eye. Patients taking isotretinoin (Accutane, Amnesteem, Claravis, Sotret) regularly suffer from a dry eye condition, which can be extremely uncomfortable, and, if left untreated, can damage the tissues of the eye’s surface or the cornea of the eye, which can lead to vision loss. But before telling patients to discontinue their isotretinoin treatments, there are a number of ways to treat this condition and bring relief to your patients. Eric Donnenfeld, M.D., a Founding Partner of the Ophthalmic Consultants of Long Island in New York and Co-Chairman of Cornea and External Disease at Manhattan Eye and Ear Hospital in New York City, says that the first step in treating dry eye is to assess the damage with a supravital stain, such as lissamine green or rose bengal. It’s important to include patients in the decision for therapy for this condition. If the patient knows the risks of dry eye and is willing to try different treatments in order to stay on isotretinoin, there are many available treatments. But, says Dr. Donnenfeld, if damage to the central cornea, which can affect vision, is found, isotretinoin should be discontinued. First-line therapy is to treat the dry eyes with artificial tears, according to Dr. Donnenfeld, who recommends transiently preserved tears, such as Refresh, TheraTears and Genteal. Patients should be instructed to use the drops four times per day for as long as necessary. If the drops don’t help, the next step would be to add a viscous ointment gel at night, such as TheraTears Liquid Gel or Refresh Liquagel, or an ointment such as Refresh P.M. According to Dr. Donnenfeld, this line of therapy works on about 50% of patients in relieving dry eye symptoms. If the damage from dry eye is more advanced, Dr. Donnenfeld recommends cyclosporin ophthalmic emulsion (Restasis). This product is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation. Dr. Donnenfeld explains that this immunomodulator actually reverses dry eye and improves the quality of the patient’s own tears. Cyclosporin ophthalmic emulsion should be used twice a day and results are typically seen after 1 month of treatment. Counsel patients that one in seven patients may experience irritation when they first start with this treatment. Tacrolimus eye drops are also currently under FDA investigation as a treatment for dry eye. In the Pipeline Another treatment option on the horizon for dry eye is mucous-secreting agonists, which will allow patients to secrete more mucus to relieve dry eye symptoms. The FDA has recently granted priority review status to Inspire Pharmaceuticals Inc.’s application for the approval of diquafosol tetrasodium (INS365) as a topical medication for dry eye disease. Diquafosol is administered topically to stimulate fluid flux across the conjunctiva and to stimulate mucin release from goblet cells. Phase II and III clinical trials revealed that diquafosol was superior to placebo lubricant therapy in improving corneal surface staining and easing symptoms of foreign body sensation. The clinical trials also showed that the medication was well tolerated. Other Therapies Dr. Donnenfeld says that oral nutritional supplements that contain flaxseed oil and omega-3 fatty acids have also been shown to improve dry eye conditions by improving secretion of tears and tear film. He recommends patients take two ThearTears Nutrition pills two times per day. Editor’s Note: Dr. Donnenfeld is a consultant with Allergan, Alcon and Bausch and Lomb. He can be reached at eddoph@aol.com. Role of Bacteria in Rosacea News from the National Rosacea Society. A National Rosacea Society-funded study by Dr. Kevin Kavanagh and colleagues at the National University of Ireland, Maynooth, found a possible role for bacteria associated with microscopic mites in the development of subtype 2 (papulopustular) rosacea. The researchers found that the bacterium Bacillus oleronius stimulated an immune system response, including high levels of T-cell proliferation, in 79% of patients with subtype 2 rosacea, compared with 29% of patients without rosacea. This bacterium is found in Demodex folliculorum, which are normal inhabitants of human skin and are often found in much greater numbers in patients with rosacea. Dr. Kavanagh explained that there are many reasons why the Demodex and bacteria interact to cause inflammation in rosacea. One possibility is that the Demodex mites carry the bacteria to areas of the face susceptible to the changes of rosacea, resulting in higher density of bacteria that produce the papules and pustules of rosacea. Or, the mites may be attracted to skin with a lot of this bacteria. Another possibility is that the Demodex mites in rosacea patients are infected with the bacteria, which produce a stimulatory antigen that triggers the disorder in susceptible patients, according to Dr. Kavanagh. The researchers reported that the role of the bacteria in causing papulopustular rosacea is supported by the fact that initial typical treatment for rosacea includes oral antibiotics that destroy B. oleronius and that antibiotics that aren’t harmful to these bacterial are usually ineffective in treating rosacea. According to the National Rosacea Society, Dr. Kavanagh and the other researchers are now developing antibodies against the antigen produced by B. oleronius to confirm its presence on the faces of patients with papulopustular rosacea and to define its relationship with Demodex mites. Once-A-Day Gel Versus Twice-A-Day Solution A comparison of the efficacy and safety. A multi-center, investigator-masked, randomized, active and placebo-controlled, parallel group comparison was conducted to demonstrate similar efficacy and to assess safety of clindamycin gel 1% once a day versus clindamycin topical solution 1% twice a day. Investigators, M. Alirezai, B. Gerlach, A. Horvath, D. Forsea, P. Briantais and M. Guyomar, under sponsorship from Galderma, also looked at the gel versus its vehicle. Results were presented in a poster at the annual AAD meeting in February. Of the 592 patients enrolled in the study, 530 completed the study. Patients received clindamycin gel 1% (265 patients) once a day, clindamycin topical solution 1% (261 patients) twice a day or clindamycin gel vehicle (66 patients) once a day. Study products were applied to the face for 12 weeks, with evaluations at weeks 4, 8 and 12. The reduction in inflammatory lesion counts after 12 weeks of treatment was similar with 62.2% in the gel group and 65.3% in the solution group. The clindamycin gel 1% was found to be significantly superior to its vehicle (50.6%) after 12 weeks of treatment (p=0.006). The percent reduction from baseline in total lesion count at endpoint was not statistically significant between the gel (52.6%) and the topical solution (56.9%). However, the difference between the gel and its vehicle (43.6%) was statistically significant (p=0.009). In terms of safety, slightly less adverse events related to the treatment occurred in the gel group (6; 2.3%) compared to the topical solution group (9; 3.4%). The vehicle group only had one adverse event. Researchers concluded that the efficacy of the once-a-day water-based gel was equal to that of the twice-a-day topical solution, and the gel was significantly superior to its vehicle. All were safe. Comparing Benzoyl Peroxide Washes How effective are these products in fighting P. acnes? In order to evaluate the antibacterial efficacy of four formulations of benzoyl peroxide cleansers against Propionibacterium acnes, researchers from Stiefel Laboratories conducted an in vitro kill-rate study. Investigators, Patricia M. Savoie, Nadia Whitbeck and Joanee M. Fraser, Ph.D., tested four products that contained benzoyl peroxide at 3%, 4%, 4% and 5%, respectively, each in a different cleansing base. Each product was diluted 1:5 with TAT broth to which P. acnes were then added. Investigators then removed, neutralized and plated for incubation 1 g aliquots at 20-second, 1-minute and 5-minute intervals. Investigators looked at these time frames because the way people typically use washes or cleansers involves applying the product to their face and rinsing it off with water after waiting a few seconds or minutes. Colony forming units were also counted after 4 days of incubation at 32 to 35 degrees Celsius under anaerobic conditions. In this study, the 3% cleanser was not found to be effective in reducing P. acnes at the 1 to 5 dilution. The 4% cleansing lotion and the 5% wash were somewhat effective with log reductions of approximately 2. Lastly, the 4% creamy wash was found to be very effective with more than a 3 log reduction in P. acnes. It’s important to note that the comparative clinical effectiveness of these wash-off products was not tested in this study.
A cne and rosacea are some of the most common conditions you treat everyday. And patients are always looking for better, faster treatments. Here, we’ll highlight some of the latest news and trends about the acne and rosacea prescription market and present details of new research about these conditions. A Slowly Growing Global Market The forecast for acne and rosacea drugs. In 2003, the global market for prescription acne and rosacea products reached revenues of $1.6 billion, a 0.2% increase from 1998, according to a report from Kalorama Information, a publishing division of MarketResearch.com. The report found that growth in general was reduced due to the patent expiration of the isotretinoin, Accutane, and new generic competition. For 2003, the largest growth in this market was seen in the retinoid segment with a 62% share of the total market. And while this is still the largest segment, again the patent expiration of Accutane in February 2002 led to a decline in market share. According to Kalorama, since the patent expiration, sales for Accutane have decreased by half in 2003. Growth for this acne and rosacea global market is forecast to reach revenues of $2.2 billion in 2008, which demonstrates a compound annual growth rate of 6.7% from 2003 to 2008. United States Sees Decline in Acne/Rosacea Market Negative growth seen from 1998 to 2003. While the global market has continued to grow, the U.S. market for prescription anti-acne and rosacea drugs reached $597.3 million in 2003, which was a 9.3% decrease from 1998. The patent expiration of Accutane, a retinoid, was a key factor in the decline in the U.S. market, but this was offset by the introduction of newer formulations of the tretinoin, Retin-A, and growth in other segments, which contributed to overall growth in the global market. The forecast for the U.S. acne and rosacea market is for growth. According to Kalorama Information research, the market will grow to $738.5 million in 2008, which reflects a 4.3% compound annual growth rate for 2003 to 2008. The growth forecast is attributed to the effectiveness of current products and to reasonable prices for products because of the increased generic competition. New products approvals will also add to the market. Safety and Efficacy of Combination Gel to Treat Acne Analysis of six controlled trials. Researchers evaluated the combined data analysis of six controlled European studies using the combination gel clindamycin phosphate 1%/tretinoin 0.025% (Velac Gel) versus either product alone in treating moderate to severe acne vulgaris. The safety and efficacy of the combination gel was investigated in six active-controlled, parallel group studies conducted by Yamanouchi Europe B.V. Data from the studies were then combined to provide an integrated analysis of safety and efficacy. J. Leyden, M.D., of the Hospital of the University of Pennsylvania, and A. Yaroshinsky, Ph.D., of Connetics Corporation, presented the findings in a poster at the Annual American Academy of Dermatology meeting in February. Males and females aged 14 to 26 with moderate to severe acne vulgaris (>3 Cook’s global assessment scale) were enrolled in the studies. Participants were given products to apply to the face once a day for 12 weeks and efficacy assessments included the percent change from baseline to week 12 in lesion count (inflammatory, non-inflammatory and total), and the proportion of patients with treatment success defined as a Cook’s Investigator’s Global Assessment score of clear or almost clear. Analysis of the studies showed that the combination gel was more effective in the treatment of acne than either product alone. (See the table below for more details.) It was also well-tolerated. New Treatments for a Common Side Effect of Isotretinoin The best ways to treat dry eye. Patients taking isotretinoin (Accutane, Amnesteem, Claravis, Sotret) regularly suffer from a dry eye condition, which can be extremely uncomfortable, and, if left untreated, can damage the tissues of the eye’s surface or the cornea of the eye, which can lead to vision loss. But before telling patients to discontinue their isotretinoin treatments, there are a number of ways to treat this condition and bring relief to your patients. Eric Donnenfeld, M.D., a Founding Partner of the Ophthalmic Consultants of Long Island in New York and Co-Chairman of Cornea and External Disease at Manhattan Eye and Ear Hospital in New York City, says that the first step in treating dry eye is to assess the damage with a supravital stain, such as lissamine green or rose bengal. It’s important to include patients in the decision for therapy for this condition. If the patient knows the risks of dry eye and is willing to try different treatments in order to stay on isotretinoin, there are many available treatments. But, says Dr. Donnenfeld, if damage to the central cornea, which can affect vision, is found, isotretinoin should be discontinued. First-line therapy is to treat the dry eyes with artificial tears, according to Dr. Donnenfeld, who recommends transiently preserved tears, such as Refresh, TheraTears and Genteal. Patients should be instructed to use the drops four times per day for as long as necessary. If the drops don’t help, the next step would be to add a viscous ointment gel at night, such as TheraTears Liquid Gel or Refresh Liquagel, or an ointment such as Refresh P.M. According to Dr. Donnenfeld, this line of therapy works on about 50% of patients in relieving dry eye symptoms. If the damage from dry eye is more advanced, Dr. Donnenfeld recommends cyclosporin ophthalmic emulsion (Restasis). This product is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation. Dr. Donnenfeld explains that this immunomodulator actually reverses dry eye and improves the quality of the patient’s own tears. Cyclosporin ophthalmic emulsion should be used twice a day and results are typically seen after 1 month of treatment. Counsel patients that one in seven patients may experience irritation when they first start with this treatment. Tacrolimus eye drops are also currently under FDA investigation as a treatment for dry eye. In the Pipeline Another treatment option on the horizon for dry eye is mucous-secreting agonists, which will allow patients to secrete more mucus to relieve dry eye symptoms. The FDA has recently granted priority review status to Inspire Pharmaceuticals Inc.’s application for the approval of diquafosol tetrasodium (INS365) as a topical medication for dry eye disease. Diquafosol is administered topically to stimulate fluid flux across the conjunctiva and to stimulate mucin release from goblet cells. Phase II and III clinical trials revealed that diquafosol was superior to placebo lubricant therapy in improving corneal surface staining and easing symptoms of foreign body sensation. The clinical trials also showed that the medication was well tolerated. Other Therapies Dr. Donnenfeld says that oral nutritional supplements that contain flaxseed oil and omega-3 fatty acids have also been shown to improve dry eye conditions by improving secretion of tears and tear film. He recommends patients take two ThearTears Nutrition pills two times per day. Editor’s Note: Dr. Donnenfeld is a consultant with Allergan, Alcon and Bausch and Lomb. He can be reached at eddoph@aol.com. Role of Bacteria in Rosacea News from the National Rosacea Society. A National Rosacea Society-funded study by Dr. Kevin Kavanagh and colleagues at the National University of Ireland, Maynooth, found a possible role for bacteria associated with microscopic mites in the development of subtype 2 (papulopustular) rosacea. The researchers found that the bacterium Bacillus oleronius stimulated an immune system response, including high levels of T-cell proliferation, in 79% of patients with subtype 2 rosacea, compared with 29% of patients without rosacea. This bacterium is found in Demodex folliculorum, which are normal inhabitants of human skin and are often found in much greater numbers in patients with rosacea. Dr. Kavanagh explained that there are many reasons why the Demodex and bacteria interact to cause inflammation in rosacea. One possibility is that the Demodex mites carry the bacteria to areas of the face susceptible to the changes of rosacea, resulting in higher density of bacteria that produce the papules and pustules of rosacea. Or, the mites may be attracted to skin with a lot of this bacteria. Another possibility is that the Demodex mites in rosacea patients are infected with the bacteria, which produce a stimulatory antigen that triggers the disorder in susceptible patients, according to Dr. Kavanagh. The researchers reported that the role of the bacteria in causing papulopustular rosacea is supported by the fact that initial typical treatment for rosacea includes oral antibiotics that destroy B. oleronius and that antibiotics that aren’t harmful to these bacterial are usually ineffective in treating rosacea. According to the National Rosacea Society, Dr. Kavanagh and the other researchers are now developing antibodies against the antigen produced by B. oleronius to confirm its presence on the faces of patients with papulopustular rosacea and to define its relationship with Demodex mites. Once-A-Day Gel Versus Twice-A-Day Solution A comparison of the efficacy and safety. A multi-center, investigator-masked, randomized, active and placebo-controlled, parallel group comparison was conducted to demonstrate similar efficacy and to assess safety of clindamycin gel 1% once a day versus clindamycin topical solution 1% twice a day. Investigators, M. Alirezai, B. Gerlach, A. Horvath, D. Forsea, P. Briantais and M. Guyomar, under sponsorship from Galderma, also looked at the gel versus its vehicle. Results were presented in a poster at the annual AAD meeting in February. Of the 592 patients enrolled in the study, 530 completed the study. Patients received clindamycin gel 1% (265 patients) once a day, clindamycin topical solution 1% (261 patients) twice a day or clindamycin gel vehicle (66 patients) once a day. Study products were applied to the face for 12 weeks, with evaluations at weeks 4, 8 and 12. The reduction in inflammatory lesion counts after 12 weeks of treatment was similar with 62.2% in the gel group and 65.3% in the solution group. The clindamycin gel 1% was found to be significantly superior to its vehicle (50.6%) after 12 weeks of treatment (p=0.006). The percent reduction from baseline in total lesion count at endpoint was not statistically significant between the gel (52.6%) and the topical solution (56.9%). However, the difference between the gel and its vehicle (43.6%) was statistically significant (p=0.009). In terms of safety, slightly less adverse events related to the treatment occurred in the gel group (6; 2.3%) compared to the topical solution group (9; 3.4%). The vehicle group only had one adverse event. Researchers concluded that the efficacy of the once-a-day water-based gel was equal to that of the twice-a-day topical solution, and the gel was significantly superior to its vehicle. All were safe. Comparing Benzoyl Peroxide Washes How effective are these products in fighting P. acnes? In order to evaluate the antibacterial efficacy of four formulations of benzoyl peroxide cleansers against Propionibacterium acnes, researchers from Stiefel Laboratories conducted an in vitro kill-rate study. Investigators, Patricia M. Savoie, Nadia Whitbeck and Joanee M. Fraser, Ph.D., tested four products that contained benzoyl peroxide at 3%, 4%, 4% and 5%, respectively, each in a different cleansing base. Each product was diluted 1:5 with TAT broth to which P. acnes were then added. Investigators then removed, neutralized and plated for incubation 1 g aliquots at 20-second, 1-minute and 5-minute intervals. Investigators looked at these time frames because the way people typically use washes or cleansers involves applying the product to their face and rinsing it off with water after waiting a few seconds or minutes. Colony forming units were also counted after 4 days of incubation at 32 to 35 degrees Celsius under anaerobic conditions. In this study, the 3% cleanser was not found to be effective in reducing P. acnes at the 1 to 5 dilution. The 4% cleansing lotion and the 5% wash were somewhat effective with log reductions of approximately 2. Lastly, the 4% creamy wash was found to be very effective with more than a 3 log reduction in P. acnes. It’s important to note that the comparative clinical effectiveness of these wash-off products was not tested in this study.
