ADVERTISEMENT
Risky Sun Behavior In Young Americans
October 2004
Most children and adolescents aren’t practicing skin protection behaviors, according to a new American Cancer Society report, “Cancer Prevention & Early Detection Facts & Figures 2004.”
Here’s a look at some highlights from the report.
• One in four parents did not require their children (12 or younger) to used any protective behaviors, according to a study by the Centers for Disease Control and Prevention.
• An American Cancer Society study found that less than one in three adolescents (11 to 18 years old) used any sun protection, such as hats, long-sleeved shirts, long pants or sunscreen.
• 72% of youths (11 to 18 years old) reported getting a sunburn during the summer.
• One in 10 youths (11 to 18 years old) used tanning lamps, with 15.6% of girls and 25.7% of those aged 17 to 18 most likely to use them.
• Only 12 states and the District of Columbia required sun safety as a part of elementary school health education.
For more information or to download the entire report, visit www.cancer.org/statistics.
Potential Cure for Controversies over Bundling and Downcoding
The American Medical Association for the first time is looking to formally study the feasibility of developing a national standard for using codes, code combinations and modifiers, according to American Medical News.
The AMA has already voted to examine a national standard that is already consistent with CPT guidelines and one that could be used by all insurance companies.
Adoption of such a standard, according to supporters, would decrease the cost to doctors of filing for insurance reimbursements. In addition, it would create set guidelines for code combinations that would end unfair bundling and downcoding by payers — which is a major reason for many of the recent lawsuits from physicians against payers.
In Brief
CollaGenex Pharmaceuticals Announced … it has filed to adopt the trademark of Oracea for Col-101, a once-daily, modified-release formulation of doxycycline 40 mg for the treatment of rosacea. Currently, two double-blinded, placebo-controlled Phase III clinical studies are each enrolling up to 264 patients at a total of 28 investigational centers. The studies will evaluate the clinical indices of rosacea, including reductions in inflammatory lesions and erythema for a 16-week period of administration. Enrollment is expected to be completed by the end of this year.
Healthpoint and Barrier Therapeutics … have collaborated to expand development of the topical antifungal agent miconazole nitrate 0.25% (Zimycan). Phase III clinical trials with the drug are completed for the treatment of infants with proven Candida-associated diaper dermatitis. Under the agreement, Healthpoint will financially back further clinical development of Zimycan for an adult indication. In addition, the company will have exclusive rights to market this drug for all approved indications to healthcare institutions in the United States and Canada.
Lumenis Recently Announced … that its IPL Quantum SR will be used as part of new multicenter Phase II clinical study to be carried out by DUSA Pharmaceuticals. Lumenis has signed a development agreement with DUSA. The first phase of the multicenter study, which will focus on rejuvenation of photodamaged skin, will involve 64 patients and will establish the best light dosages for photodynamic therapy using the IPL Quantum SR. The second phase will involve up to 60 patients who will receive multiple treatments of fixed light doses. One side of each patient’s face will be selected at random to receive control treatment and one side will be treated topically with Levulan. The study hopes to show that treatment is improved when IPL is used in conjunction with Levulan.
Stiefel Labs Celebrates … 1-million prescription mark for Duac Topical Gel (1% clindamycin/5% benzoyl peroxide) with a $10,000 contribution to Camp Discovery, a summer camp sponsored by the American Academy of Dermatology (AAD) for young people with a serious skin condition.
The National Rosacea Society Introduced … a new consumer booklet called the “Rosacea Diary” to help patients find and avoid environmental and lifestyle factors that may trigger or aggravate their individual cases of this conspicuous facial disorder estimated to affect 14 million Americans. To order bulk quantities for use as handouts to patients with rosacea, contact the society by calling (888) No-Blush or by e-mailing rosaceas@aol.com. The booklet was made possible by an unrestricted educational grant from Stiefel Laboratories.
Allergan Announced Formation … of new Dermatology and Neurosciences business units in the United States. The company named Lynn Sale and Bob Rhatigan Vice Presidents of the two new business units, Neurosciences and Dermatology, respectively. Mr. Rhatigan will be heading up the Dermatology business unit, which includes Botox Cosmetic and Tazorac (tazarotene). Mr. Rhatigan most recently led the U.S. Botox sales and marketing organization and has been resonsible for several other products and marketing programs at Allergan for the past 8 years.
New Study Shows Hyperhidrosis … affects nearly three times as many people as previously thought. Results of this first-ever national survey to determine the prevalence of hyperhidrosis was published in the Journal of the American Academy of Dermatology (JAAD). The survey found that as many as 7.8 million American (2.8% of the population) may have hyperhidrosis. The study also found that 1.3 million people have severe underarm sweating that they report is intolerable or barely tolerable and that it always or frequently interferes with their daily activities. However, the survey showed that despite the prevalence and the range of available treatments only a minority of patients ever consult their doctors about the condition.
The Women’s Dermatologic Society … announced that LPGA Tour Golf Professional Angela Jerman was the official spokesperson for the WDS’s Play Safe in the Sun Campaingn at the Safeway Classic LPGA Championship. The tournament, held at Columbia Edgewater Country Club in Portland, OR, September 16 through 19, helped raise awarenes about the importance of sun protection and early detection to reduce the skin cancer epidemic in the United States. The WDS provided free skin cancer screenings in conjuction with the championship.
FDA Approvals And News
New Drug Application For Acne Treatment
Fujisawa Healthcare and Atrix Laboratories announced that they submitted a New Drug Application (NDA) to the FDA for Aczone Gel 5%, a dapsone topical gel formerly called Atrisone, for the treatment of acne vulgaris. The NDA was submitted in late August.
The drug uses Atrix’s proprietary Solvent Microparticle (SMP) delivery system to deliver dapsone, a water-insoluble compound with anti-inflammatory and anti-microbial properties. Atrix’s SMP system allows localized delivery of dapsone, which is currently only commercially available for other indications as an oral tablet for systemic delivery due to the compound’s water insolubility.
Updated Restylane Information
The manufacturer of the filler Restylane, Q-Med Scandinavia Inc., has received approval from FDA to increase the expiration dating for Restylane from 24 months to 36 months.
Other FDA Drug News
Phase I Trial results … were announced for Psoraxine at the 2004 National Conference of the U.S. National Psoriasis Foundation in August, according to Astralis, SkyePharma Inc.’s partner. Dr. Jose O’Daly, the Chairman and Chief Executive of Astralis, presented the results of this novel injectable treatment for moderate psoriasis.
The Phase I trial, which began in September 2003, was a randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the safety of Psoraxine. Psoraxine was given to 21 patients with moderate and clinically stable plaque psoriasis via a single intramuscular injection treatment. Treatment was generally well tolerated in patients with active but stable plaque psoriasis, with similar safely profiles among patients who received single doses of placebo or Psoraxine at doses of 50 mg, 150 mg or 300 mg. None of the patients evaluated developed skin anergy to standard recall antigens during the study.
Xoma Ltd. Announced … that preliminary results of a Phase II trial with XMP.629 gel, a topical peptide formulation for the treatment of mild-to-moderate acne, were inconclusive in terms of clinical benefit compared to vehicle gel. The double-blind, randomized, controlled study enrolled 253 patients and was designed to evaluate safety, tolerability at efficacy. Patients were dosed with either vehicle gel or one of three dosages of XMP.629 gel — 0.01%, 0.05% or 0.1% — administered nightly for 12 weeks. The primary endpoint of this study was to compare the percentage change from baseline to week 12 for inflammatory lesion counts, non-inflammatory lesion counts and total lesion counts between patients applying XMP.629 gel and those receiving vehicle gel. The study also evaluated the number of patients who were clear to almost clear after 12 weeks. There was no discernable dose response and the vehicle response was higher than anticipated. The drug did appear to be safe and well tolerated.
Labeling Change for Efudex
The contraindications and warning sections of the safety label for Efudex (fluorouracil) was changed in June. The FDA-approved changes state that Efudex shouldn’t be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. There have been rare life-threatening toxicities, such as stomatitis, diarrhea, neutropenia and neurotoxicity, reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. The warnings section now says, “Patients should discontinue therapy with Efudex if symptoms of DPD enzyme deficiency develop.”
Most children and adolescents aren’t practicing skin protection behaviors, according to a new American Cancer Society report, “Cancer Prevention & Early Detection Facts & Figures 2004.”
Here’s a look at some highlights from the report.
• One in four parents did not require their children (12 or younger) to used any protective behaviors, according to a study by the Centers for Disease Control and Prevention.
• An American Cancer Society study found that less than one in three adolescents (11 to 18 years old) used any sun protection, such as hats, long-sleeved shirts, long pants or sunscreen.
• 72% of youths (11 to 18 years old) reported getting a sunburn during the summer.
• One in 10 youths (11 to 18 years old) used tanning lamps, with 15.6% of girls and 25.7% of those aged 17 to 18 most likely to use them.
• Only 12 states and the District of Columbia required sun safety as a part of elementary school health education.
For more information or to download the entire report, visit www.cancer.org/statistics.
Potential Cure for Controversies over Bundling and Downcoding
The American Medical Association for the first time is looking to formally study the feasibility of developing a national standard for using codes, code combinations and modifiers, according to American Medical News.
The AMA has already voted to examine a national standard that is already consistent with CPT guidelines and one that could be used by all insurance companies.
Adoption of such a standard, according to supporters, would decrease the cost to doctors of filing for insurance reimbursements. In addition, it would create set guidelines for code combinations that would end unfair bundling and downcoding by payers — which is a major reason for many of the recent lawsuits from physicians against payers.
In Brief
CollaGenex Pharmaceuticals Announced … it has filed to adopt the trademark of Oracea for Col-101, a once-daily, modified-release formulation of doxycycline 40 mg for the treatment of rosacea. Currently, two double-blinded, placebo-controlled Phase III clinical studies are each enrolling up to 264 patients at a total of 28 investigational centers. The studies will evaluate the clinical indices of rosacea, including reductions in inflammatory lesions and erythema for a 16-week period of administration. Enrollment is expected to be completed by the end of this year.
Healthpoint and Barrier Therapeutics … have collaborated to expand development of the topical antifungal agent miconazole nitrate 0.25% (Zimycan). Phase III clinical trials with the drug are completed for the treatment of infants with proven Candida-associated diaper dermatitis. Under the agreement, Healthpoint will financially back further clinical development of Zimycan for an adult indication. In addition, the company will have exclusive rights to market this drug for all approved indications to healthcare institutions in the United States and Canada.
Lumenis Recently Announced … that its IPL Quantum SR will be used as part of new multicenter Phase II clinical study to be carried out by DUSA Pharmaceuticals. Lumenis has signed a development agreement with DUSA. The first phase of the multicenter study, which will focus on rejuvenation of photodamaged skin, will involve 64 patients and will establish the best light dosages for photodynamic therapy using the IPL Quantum SR. The second phase will involve up to 60 patients who will receive multiple treatments of fixed light doses. One side of each patient’s face will be selected at random to receive control treatment and one side will be treated topically with Levulan. The study hopes to show that treatment is improved when IPL is used in conjunction with Levulan.
Stiefel Labs Celebrates … 1-million prescription mark for Duac Topical Gel (1% clindamycin/5% benzoyl peroxide) with a $10,000 contribution to Camp Discovery, a summer camp sponsored by the American Academy of Dermatology (AAD) for young people with a serious skin condition.
The National Rosacea Society Introduced … a new consumer booklet called the “Rosacea Diary” to help patients find and avoid environmental and lifestyle factors that may trigger or aggravate their individual cases of this conspicuous facial disorder estimated to affect 14 million Americans. To order bulk quantities for use as handouts to patients with rosacea, contact the society by calling (888) No-Blush or by e-mailing rosaceas@aol.com. The booklet was made possible by an unrestricted educational grant from Stiefel Laboratories.
Allergan Announced Formation … of new Dermatology and Neurosciences business units in the United States. The company named Lynn Sale and Bob Rhatigan Vice Presidents of the two new business units, Neurosciences and Dermatology, respectively. Mr. Rhatigan will be heading up the Dermatology business unit, which includes Botox Cosmetic and Tazorac (tazarotene). Mr. Rhatigan most recently led the U.S. Botox sales and marketing organization and has been resonsible for several other products and marketing programs at Allergan for the past 8 years.
New Study Shows Hyperhidrosis … affects nearly three times as many people as previously thought. Results of this first-ever national survey to determine the prevalence of hyperhidrosis was published in the Journal of the American Academy of Dermatology (JAAD). The survey found that as many as 7.8 million American (2.8% of the population) may have hyperhidrosis. The study also found that 1.3 million people have severe underarm sweating that they report is intolerable or barely tolerable and that it always or frequently interferes with their daily activities. However, the survey showed that despite the prevalence and the range of available treatments only a minority of patients ever consult their doctors about the condition.
The Women’s Dermatologic Society … announced that LPGA Tour Golf Professional Angela Jerman was the official spokesperson for the WDS’s Play Safe in the Sun Campaingn at the Safeway Classic LPGA Championship. The tournament, held at Columbia Edgewater Country Club in Portland, OR, September 16 through 19, helped raise awarenes about the importance of sun protection and early detection to reduce the skin cancer epidemic in the United States. The WDS provided free skin cancer screenings in conjuction with the championship.
FDA Approvals And News
New Drug Application For Acne Treatment
Fujisawa Healthcare and Atrix Laboratories announced that they submitted a New Drug Application (NDA) to the FDA for Aczone Gel 5%, a dapsone topical gel formerly called Atrisone, for the treatment of acne vulgaris. The NDA was submitted in late August.
The drug uses Atrix’s proprietary Solvent Microparticle (SMP) delivery system to deliver dapsone, a water-insoluble compound with anti-inflammatory and anti-microbial properties. Atrix’s SMP system allows localized delivery of dapsone, which is currently only commercially available for other indications as an oral tablet for systemic delivery due to the compound’s water insolubility.
Updated Restylane Information
The manufacturer of the filler Restylane, Q-Med Scandinavia Inc., has received approval from FDA to increase the expiration dating for Restylane from 24 months to 36 months.
Other FDA Drug News
Phase I Trial results … were announced for Psoraxine at the 2004 National Conference of the U.S. National Psoriasis Foundation in August, according to Astralis, SkyePharma Inc.’s partner. Dr. Jose O’Daly, the Chairman and Chief Executive of Astralis, presented the results of this novel injectable treatment for moderate psoriasis.
The Phase I trial, which began in September 2003, was a randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the safety of Psoraxine. Psoraxine was given to 21 patients with moderate and clinically stable plaque psoriasis via a single intramuscular injection treatment. Treatment was generally well tolerated in patients with active but stable plaque psoriasis, with similar safely profiles among patients who received single doses of placebo or Psoraxine at doses of 50 mg, 150 mg or 300 mg. None of the patients evaluated developed skin anergy to standard recall antigens during the study.
Xoma Ltd. Announced … that preliminary results of a Phase II trial with XMP.629 gel, a topical peptide formulation for the treatment of mild-to-moderate acne, were inconclusive in terms of clinical benefit compared to vehicle gel. The double-blind, randomized, controlled study enrolled 253 patients and was designed to evaluate safety, tolerability at efficacy. Patients were dosed with either vehicle gel or one of three dosages of XMP.629 gel — 0.01%, 0.05% or 0.1% — administered nightly for 12 weeks. The primary endpoint of this study was to compare the percentage change from baseline to week 12 for inflammatory lesion counts, non-inflammatory lesion counts and total lesion counts between patients applying XMP.629 gel and those receiving vehicle gel. The study also evaluated the number of patients who were clear to almost clear after 12 weeks. There was no discernable dose response and the vehicle response was higher than anticipated. The drug did appear to be safe and well tolerated.
Labeling Change for Efudex
The contraindications and warning sections of the safety label for Efudex (fluorouracil) was changed in June. The FDA-approved changes state that Efudex shouldn’t be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. There have been rare life-threatening toxicities, such as stomatitis, diarrhea, neutropenia and neurotoxicity, reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. The warnings section now says, “Patients should discontinue therapy with Efudex if symptoms of DPD enzyme deficiency develop.”
Most children and adolescents aren’t practicing skin protection behaviors, according to a new American Cancer Society report, “Cancer Prevention & Early Detection Facts & Figures 2004.”
Here’s a look at some highlights from the report.
• One in four parents did not require their children (12 or younger) to used any protective behaviors, according to a study by the Centers for Disease Control and Prevention.
• An American Cancer Society study found that less than one in three adolescents (11 to 18 years old) used any sun protection, such as hats, long-sleeved shirts, long pants or sunscreen.
• 72% of youths (11 to 18 years old) reported getting a sunburn during the summer.
• One in 10 youths (11 to 18 years old) used tanning lamps, with 15.6% of girls and 25.7% of those aged 17 to 18 most likely to use them.
• Only 12 states and the District of Columbia required sun safety as a part of elementary school health education.
For more information or to download the entire report, visit www.cancer.org/statistics.
Potential Cure for Controversies over Bundling and Downcoding
The American Medical Association for the first time is looking to formally study the feasibility of developing a national standard for using codes, code combinations and modifiers, according to American Medical News.
The AMA has already voted to examine a national standard that is already consistent with CPT guidelines and one that could be used by all insurance companies.
Adoption of such a standard, according to supporters, would decrease the cost to doctors of filing for insurance reimbursements. In addition, it would create set guidelines for code combinations that would end unfair bundling and downcoding by payers — which is a major reason for many of the recent lawsuits from physicians against payers.
In Brief
CollaGenex Pharmaceuticals Announced … it has filed to adopt the trademark of Oracea for Col-101, a once-daily, modified-release formulation of doxycycline 40 mg for the treatment of rosacea. Currently, two double-blinded, placebo-controlled Phase III clinical studies are each enrolling up to 264 patients at a total of 28 investigational centers. The studies will evaluate the clinical indices of rosacea, including reductions in inflammatory lesions and erythema for a 16-week period of administration. Enrollment is expected to be completed by the end of this year.
Healthpoint and Barrier Therapeutics … have collaborated to expand development of the topical antifungal agent miconazole nitrate 0.25% (Zimycan). Phase III clinical trials with the drug are completed for the treatment of infants with proven Candida-associated diaper dermatitis. Under the agreement, Healthpoint will financially back further clinical development of Zimycan for an adult indication. In addition, the company will have exclusive rights to market this drug for all approved indications to healthcare institutions in the United States and Canada.
Lumenis Recently Announced … that its IPL Quantum SR will be used as part of new multicenter Phase II clinical study to be carried out by DUSA Pharmaceuticals. Lumenis has signed a development agreement with DUSA. The first phase of the multicenter study, which will focus on rejuvenation of photodamaged skin, will involve 64 patients and will establish the best light dosages for photodynamic therapy using the IPL Quantum SR. The second phase will involve up to 60 patients who will receive multiple treatments of fixed light doses. One side of each patient’s face will be selected at random to receive control treatment and one side will be treated topically with Levulan. The study hopes to show that treatment is improved when IPL is used in conjunction with Levulan.
Stiefel Labs Celebrates … 1-million prescription mark for Duac Topical Gel (1% clindamycin/5% benzoyl peroxide) with a $10,000 contribution to Camp Discovery, a summer camp sponsored by the American Academy of Dermatology (AAD) for young people with a serious skin condition.
The National Rosacea Society Introduced … a new consumer booklet called the “Rosacea Diary” to help patients find and avoid environmental and lifestyle factors that may trigger or aggravate their individual cases of this conspicuous facial disorder estimated to affect 14 million Americans. To order bulk quantities for use as handouts to patients with rosacea, contact the society by calling (888) No-Blush or by e-mailing rosaceas@aol.com. The booklet was made possible by an unrestricted educational grant from Stiefel Laboratories.
Allergan Announced Formation … of new Dermatology and Neurosciences business units in the United States. The company named Lynn Sale and Bob Rhatigan Vice Presidents of the two new business units, Neurosciences and Dermatology, respectively. Mr. Rhatigan will be heading up the Dermatology business unit, which includes Botox Cosmetic and Tazorac (tazarotene). Mr. Rhatigan most recently led the U.S. Botox sales and marketing organization and has been resonsible for several other products and marketing programs at Allergan for the past 8 years.
New Study Shows Hyperhidrosis … affects nearly three times as many people as previously thought. Results of this first-ever national survey to determine the prevalence of hyperhidrosis was published in the Journal of the American Academy of Dermatology (JAAD). The survey found that as many as 7.8 million American (2.8% of the population) may have hyperhidrosis. The study also found that 1.3 million people have severe underarm sweating that they report is intolerable or barely tolerable and that it always or frequently interferes with their daily activities. However, the survey showed that despite the prevalence and the range of available treatments only a minority of patients ever consult their doctors about the condition.
The Women’s Dermatologic Society … announced that LPGA Tour Golf Professional Angela Jerman was the official spokesperson for the WDS’s Play Safe in the Sun Campaingn at the Safeway Classic LPGA Championship. The tournament, held at Columbia Edgewater Country Club in Portland, OR, September 16 through 19, helped raise awarenes about the importance of sun protection and early detection to reduce the skin cancer epidemic in the United States. The WDS provided free skin cancer screenings in conjuction with the championship.
FDA Approvals And News
New Drug Application For Acne Treatment
Fujisawa Healthcare and Atrix Laboratories announced that they submitted a New Drug Application (NDA) to the FDA for Aczone Gel 5%, a dapsone topical gel formerly called Atrisone, for the treatment of acne vulgaris. The NDA was submitted in late August.
The drug uses Atrix’s proprietary Solvent Microparticle (SMP) delivery system to deliver dapsone, a water-insoluble compound with anti-inflammatory and anti-microbial properties. Atrix’s SMP system allows localized delivery of dapsone, which is currently only commercially available for other indications as an oral tablet for systemic delivery due to the compound’s water insolubility.
Updated Restylane Information
The manufacturer of the filler Restylane, Q-Med Scandinavia Inc., has received approval from FDA to increase the expiration dating for Restylane from 24 months to 36 months.
Other FDA Drug News
Phase I Trial results … were announced for Psoraxine at the 2004 National Conference of the U.S. National Psoriasis Foundation in August, according to Astralis, SkyePharma Inc.’s partner. Dr. Jose O’Daly, the Chairman and Chief Executive of Astralis, presented the results of this novel injectable treatment for moderate psoriasis.
The Phase I trial, which began in September 2003, was a randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the safety of Psoraxine. Psoraxine was given to 21 patients with moderate and clinically stable plaque psoriasis via a single intramuscular injection treatment. Treatment was generally well tolerated in patients with active but stable plaque psoriasis, with similar safely profiles among patients who received single doses of placebo or Psoraxine at doses of 50 mg, 150 mg or 300 mg. None of the patients evaluated developed skin anergy to standard recall antigens during the study.
Xoma Ltd. Announced … that preliminary results of a Phase II trial with XMP.629 gel, a topical peptide formulation for the treatment of mild-to-moderate acne, were inconclusive in terms of clinical benefit compared to vehicle gel. The double-blind, randomized, controlled study enrolled 253 patients and was designed to evaluate safety, tolerability at efficacy. Patients were dosed with either vehicle gel or one of three dosages of XMP.629 gel — 0.01%, 0.05% or 0.1% — administered nightly for 12 weeks. The primary endpoint of this study was to compare the percentage change from baseline to week 12 for inflammatory lesion counts, non-inflammatory lesion counts and total lesion counts between patients applying XMP.629 gel and those receiving vehicle gel. The study also evaluated the number of patients who were clear to almost clear after 12 weeks. There was no discernable dose response and the vehicle response was higher than anticipated. The drug did appear to be safe and well tolerated.
Labeling Change for Efudex
The contraindications and warning sections of the safety label for Efudex (fluorouracil) was changed in June. The FDA-approved changes state that Efudex shouldn’t be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. There have been rare life-threatening toxicities, such as stomatitis, diarrhea, neutropenia and neurotoxicity, reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. The warnings section now says, “Patients should discontinue therapy with Efudex if symptoms of DPD enzyme deficiency develop.”
Current Issue
August 2024
Volume 32
Issue 5
Subscribe
The Dermatologist Newsletter
