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Research in Review

Atopic Dermatitis Update

July 2008

 

Atopic Dermatitis Increasing in U.S. Children

Agroup of investigators led by Dr. Kimberly A. Horii of Children’s Mercy Hospitals and Clinics in Kansas City, MO, has suggested that atopic dermatitis (AD) among U.S. children is increasing, especially among African-Americans and Asians.

Findings reported in the September issue of Pediatrics (Horii AK. Pediatrics. 2007;120:e527-534.) were based on outpatient encounters compiled from the National Ambulatory Medical Care Survey and The National Hospital Ambulatory Medical Care Survey for 1997 to 2000 and 2001 to 2004.

This increase — gauged by doctor and hospital visits for the condition — was seen among children of all races and ethnic groups, including 620,000 visits in 1997 and a peak of 1.7 million in 2003, which fell to 850,000 in 2004, with patients between ages 2 and 5 presenting at the highest rate (odds ratio 2.4 compared with children ages 11 to 18 years, P=0.001).

Compared with Caucasian patients, the odds ratios were: 1.9 for Hispanics (P=0.02); 2.2 for African-Americans (0.001); and 3.1 for Asians (P=0.001).

Among possible explanations mentioned by the researchers were an awareness of topical calcineurin inhibitors, which debuted during the peak year (2003), as well as improved hygiene, environmental substances, or a higher rate of recognition and diagnosis by physicians.

 

Study Casts Doubt on Benefit of Delayed Introduction of Solid Foods on Atopic Diseases

According to a German study that appeared in Pediatrics (Zutavern A, Brockow I, Schaaf B, et al; LISA Study Group. Pediatrics. 2008 Jan;121(1):e44-52.), it is unlikely that delaying the introduction of solid food beyond 4 to 6 months is protective against the development of eczema, asthma, allergic rhinitis, and food or inhalant sensitization at the age of 6 years.
In fact, the study found that food sensitization was even more frequent among children introduced to solids later.

Method

The prospective birth cohort study LISA utilized data from 2,073 children at 6 years of age. Multivariate logistic regression analyses were performed for all children and for children without skin or allergic symptoms within the first 6 months of life to take into account reverse causality.

Results

While the study found no benefit in relation to AD in delaying solids and, in fact, more frequent food sensitization in that group, it did find that eczema was significantly more frequent in children who received a more diverse diet within the first 4 months.
 

Relationship Between Atopic Disorder and Irritable Bowel Syndrome Studied


A group of investigators from the Department of Immunology/Microbiology at Rush University Medical Center, John H. Stoger, Jr. Hospital in Chicago conducted a study on a possible link between atopic disorders and irritable bowel syndrome (IBS) based on the observation that mast cells have a primary role in atopy.

Methods

A prospective study was designed using structured questionnaires, which were administered to 125 consecutive patients seen in the following clinics from July 1 through October 31, 2001: allergy/immunology (AI) (n=39), gastroenterology (n=36), and general medicine (n=50). The survey included questions detailing gastrointestinal and allergic symptoms. Diagnosis of IBS was based on Rome II criteria. Diagnosis of atopy was based on clinical parameters.

Results

The AI clinic reported a significantly (P = .015) higher rate of IBS than the general medicine clinic, and the IBS incidence reported in the AI clinic was similar to that reported in the gastroenterology clinic. The likelihood of IBS was significantly higher in patients with seasonal allergic rhinitis (2.67 times; 95% confidence interval [CI], 1.10-6.49; P=.03), patients with allergic eczema (3.85 times; 95% CI, 1.72-8.60; P=.001), and patients with depression (2.56 times; 95% CI, 1.05-6.14; P=.04). Patients reporting atopic symptoms (seasonal allergic rhinitis, allergic eczema, and asthma) were 3.20 times (95% CI, 1.20-8.50) (P=.02) more likely to fulfill the criteria for IBS.

Higher Incidence of IBS

Authors concluded that adults with atopic symptoms do in fact report a high incidence of IBS, suggesting a link between atopy and IBS. They further suggested that being able to establish a subgroup of atopic IBS patient vs. nonatopic IBS may help in identifying the underlying pathophysiologic mechanisms involved and therapeutic options.

Tobin MC, Moparty B, Farhadi A, DeMeo MT, Bansal PJ, Keshavarzian A. Atopic irritable bowel syndrome: a novel subgroup of irritable bowel syndrome with allergic manifestations. Ann Allergy Asthma Immunol. 2008 Jan;100(1):49-53.
 

Study Suggests Association Between Bacterium and Atopic Eczema

Bifidobacterium pseudocatenulatum, which is commonly found in the fecal microflora of infants — particularly those who are not breast fed — was found to be associated with atopic eczema, and may therefore be a biomarker for susceptibility to this atopic disease, according to Dr. Gerald W. Tannock, of the University of Otago, Dunedin, New Zealand, and colleagues who reported their findings in Journal of Allergy and Clinical Immunology. (J Allergy Clin Immunol. 2008;121:135-140.)

Study

In a nested case-control study, the researchers compared fecal bacterial communities of 37 infants 3 to 6 months of age with that of 24 infants without eczema who were matched for sex, age, feeding method, weaning, and ethnicity. They also collected information on maternal and infant antibiotic exposure, feeding, gastrointestinal symptoms, and family history of allergy.

Findings

While no significant differences in overall profiles of fecal bacterial communities were observed between cases and controls, infants with a family history of allergic disease were significantly more likely to have bifidobacteria in their feces than those without a family history (86% vs. 58%; P=0.05), as were those who were not breast fed (39% vs. 9%; P=0.01). The increased risk was confirmed in logistic regression analysis (odds ratio, 5.6; P=0.02).

B. pseudocatenulatum was also detected more commonly in children with eczema than in those without eczema (27% vs. 4%; P=0.04).
 

Cloderm Found Safest for Atopic Dermatitis

According to Dr. Matthew Zirwas, Director of the Ohio State University Contact and Occupational Dermatology Center and member of the Coria Laboratories speaker panel, the mid-potency steroid cream clocortolone pivalate (Cloderm Cream, 0.1%), has been established as an appropriate short-term therapy for dermatitis, and is the one with the lowest potential to cause an allergic reaction on the skin or to have a cross-reaction with other steroids. Cloderm Cream was said to be highly effective in treating all patients with many forms of dermatosis, including contact dermatitis, atopic dermatitis, seborrheic dermatitis, stasis dermatitis and psoriasis vulgaris.

Dr. Matthew Zirwas made these claims during the annual Hawaii Dermatology Seminar, noting that Cloderm Cream’s molecular design makes it one of only two Class C topical steroids, which rarely cross-react with another steroid, that are available in the United States.

Supporting Studies

The product’s superior safety profile is supported by a clinical study of 147 patients using the treatment for up to 40 days without atrophy, hypopigmentation or striae.

In another study, 38 subjects with a history of sensitization to steroids were given patch-test trials of 10 steroid agents in a petrolatum base, including three formulations of clocortolone pivalate, which remained on the skin initially for 48 hours. Each site was evaluated for the presence of a sensitivity reaction after 48 hours and 96 hours. Results indicated that clocortolone pivalate had the lowest rate of sensitivity reactions at both times.
Further supporting claims about the product were based on a survey of 2,927 dermatologists, 85% of whom reported that the Cloderm Cream vehicle absorbed into the skin very well, and 88% said it had no offensive odor. Lack of tackiness during and after application, as well as non-greasy appearance and feel, were also frequently reported in the survey results.

The most common adverse events with Cloderm Cream included dryness, irritation, folliculitis, acneiform eruptions and burning.
 

Methotrexate Effective and Safe for Children with Severe Atopic Dermatitis

Aposter presented at the winter meeting of the American Academy of Dermatology reported that methotrexate is an effective treatment for children with severe atopic dermatitis.

Noting that research on systemic treatment of children is limited on this most common cause of severe skin disease in children, the investigators retrospectively reviewed data on 30 children with severe atopic dermatitis who had been treated with methotrexate.

Patients ranged in age from 2 to 16 years, and all had failed topical therapy. Many had been treated with cyclosporine and were successfully switched over to methotrexate. All subjects received an initial dose of 0.5 mg/kg/week (maximum 15 mg). Most tolerated the tablet formulation, but among those who received a liquid formulation, it was most often the concentrated 25 mg/cc parenteral formulation.

Supplemental folic acid (1 mg) was added after the first month of treatment and was taken on non-methotrexate days.
Follow-up in the clinic and laboratory assessments took place at baseline and monthly for 3 months, followed every 3 months thereafter if the dosing remained stable. Laboratory parameters included complete blood counts with red blood cell indices and a comprehensive metabolic panel.

Poster authors reported that elevations in hepatic transaminases, which were transient and unusual, were found in blood obtained within 1 to 2 days after methotrexate or after a presumed viral illness. No child underwent liver biopsy.
Dose adjustments occurred every 2 to 3 months as needed.

The investigators found that the majority of methotrexate-treated subjects achieved a partial to complete response, with no serious adverse events occurring among the subjects during an average of 12 months exposure.

Methotrexate for Atopic Dermatitis in Children. Abstract P608.
 

Barrier Therapeutics Posters Support Promising Products for Atopic Diseases

At the winter AAD meeting in San Antonio, Barrier Therapeutics presented findings on promising new treatments for atopic conditions. They included pramiconazole, which is under development for both acute and chronic fungal infections, and of Hivenyl, an antihistamine that may be effective in reducing or eliminating the symptoms of itch without sedating effects.”

The poster presentations were titled:

  • Pramiconazole, a novel oral antifungal agent, effectively treats Pityriasis versicolor — results of a dose finding clinical study; Poster Number: 1704.
  • Oral vapitadine, a new non-sedating antihistamine, relieves itch associated with atopic dermatitis; Poster Number: 601; current product candidate referred to as Hivenyl.

 

 

 

Atopic Dermatitis Increasing in U.S. Children

Agroup of investigators led by Dr. Kimberly A. Horii of Children’s Mercy Hospitals and Clinics in Kansas City, MO, has suggested that atopic dermatitis (AD) among U.S. children is increasing, especially among African-Americans and Asians.

Findings reported in the September issue of Pediatrics (Horii AK. Pediatrics. 2007;120:e527-534.) were based on outpatient encounters compiled from the National Ambulatory Medical Care Survey and The National Hospital Ambulatory Medical Care Survey for 1997 to 2000 and 2001 to 2004.

This increase — gauged by doctor and hospital visits for the condition — was seen among children of all races and ethnic groups, including 620,000 visits in 1997 and a peak of 1.7 million in 2003, which fell to 850,000 in 2004, with patients between ages 2 and 5 presenting at the highest rate (odds ratio 2.4 compared with children ages 11 to 18 years, P=0.001).

Compared with Caucasian patients, the odds ratios were: 1.9 for Hispanics (P=0.02); 2.2 for African-Americans (0.001); and 3.1 for Asians (P=0.001).

Among possible explanations mentioned by the researchers were an awareness of topical calcineurin inhibitors, which debuted during the peak year (2003), as well as improved hygiene, environmental substances, or a higher rate of recognition and diagnosis by physicians.

 

Study Casts Doubt on Benefit of Delayed Introduction of Solid Foods on Atopic Diseases

According to a German study that appeared in Pediatrics (Zutavern A, Brockow I, Schaaf B, et al; LISA Study Group. Pediatrics. 2008 Jan;121(1):e44-52.), it is unlikely that delaying the introduction of solid food beyond 4 to 6 months is protective against the development of eczema, asthma, allergic rhinitis, and food or inhalant sensitization at the age of 6 years.
In fact, the study found that food sensitization was even more frequent among children introduced to solids later.

Method

The prospective birth cohort study LISA utilized data from 2,073 children at 6 years of age. Multivariate logistic regression analyses were performed for all children and for children without skin or allergic symptoms within the first 6 months of life to take into account reverse causality.

Results

While the study found no benefit in relation to AD in delaying solids and, in fact, more frequent food sensitization in that group, it did find that eczema was significantly more frequent in children who received a more diverse diet within the first 4 months.
 

Relationship Between Atopic Disorder and Irritable Bowel Syndrome Studied


A group of investigators from the Department of Immunology/Microbiology at Rush University Medical Center, John H. Stoger, Jr. Hospital in Chicago conducted a study on a possible link between atopic disorders and irritable bowel syndrome (IBS) based on the observation that mast cells have a primary role in atopy.

Methods

A prospective study was designed using structured questionnaires, which were administered to 125 consecutive patients seen in the following clinics from July 1 through October 31, 2001: allergy/immunology (AI) (n=39), gastroenterology (n=36), and general medicine (n=50). The survey included questions detailing gastrointestinal and allergic symptoms. Diagnosis of IBS was based on Rome II criteria. Diagnosis of atopy was based on clinical parameters.

Results

The AI clinic reported a significantly (P = .015) higher rate of IBS than the general medicine clinic, and the IBS incidence reported in the AI clinic was similar to that reported in the gastroenterology clinic. The likelihood of IBS was significantly higher in patients with seasonal allergic rhinitis (2.67 times; 95% confidence interval [CI], 1.10-6.49; P=.03), patients with allergic eczema (3.85 times; 95% CI, 1.72-8.60; P=.001), and patients with depression (2.56 times; 95% CI, 1.05-6.14; P=.04). Patients reporting atopic symptoms (seasonal allergic rhinitis, allergic eczema, and asthma) were 3.20 times (95% CI, 1.20-8.50) (P=.02) more likely to fulfill the criteria for IBS.

Higher Incidence of IBS

Authors concluded that adults with atopic symptoms do in fact report a high incidence of IBS, suggesting a link between atopy and IBS. They further suggested that being able to establish a subgroup of atopic IBS patient vs. nonatopic IBS may help in identifying the underlying pathophysiologic mechanisms involved and therapeutic options.

Tobin MC, Moparty B, Farhadi A, DeMeo MT, Bansal PJ, Keshavarzian A. Atopic irritable bowel syndrome: a novel subgroup of irritable bowel syndrome with allergic manifestations. Ann Allergy Asthma Immunol. 2008 Jan;100(1):49-53.
 

Study Suggests Association Between Bacterium and Atopic Eczema

Bifidobacterium pseudocatenulatum, which is commonly found in the fecal microflora of infants — particularly those who are not breast fed — was found to be associated with atopic eczema, and may therefore be a biomarker for susceptibility to this atopic disease, according to Dr. Gerald W. Tannock, of the University of Otago, Dunedin, New Zealand, and colleagues who reported their findings in Journal of Allergy and Clinical Immunology. (J Allergy Clin Immunol. 2008;121:135-140.)

Study

In a nested case-control study, the researchers compared fecal bacterial communities of 37 infants 3 to 6 months of age with that of 24 infants without eczema who were matched for sex, age, feeding method, weaning, and ethnicity. They also collected information on maternal and infant antibiotic exposure, feeding, gastrointestinal symptoms, and family history of allergy.

Findings

While no significant differences in overall profiles of fecal bacterial communities were observed between cases and controls, infants with a family history of allergic disease were significantly more likely to have bifidobacteria in their feces than those without a family history (86% vs. 58%; P=0.05), as were those who were not breast fed (39% vs. 9%; P=0.01). The increased risk was confirmed in logistic regression analysis (odds ratio, 5.6; P=0.02).

B. pseudocatenulatum was also detected more commonly in children with eczema than in those without eczema (27% vs. 4%; P=0.04).
 

Cloderm Found Safest for Atopic Dermatitis

According to Dr. Matthew Zirwas, Director of the Ohio State University Contact and Occupational Dermatology Center and member of the Coria Laboratories speaker panel, the mid-potency steroid cream clocortolone pivalate (Cloderm Cream, 0.1%), has been established as an appropriate short-term therapy for dermatitis, and is the one with the lowest potential to cause an allergic reaction on the skin or to have a cross-reaction with other steroids. Cloderm Cream was said to be highly effective in treating all patients with many forms of dermatosis, including contact dermatitis, atopic dermatitis, seborrheic dermatitis, stasis dermatitis and psoriasis vulgaris.

Dr. Matthew Zirwas made these claims during the annual Hawaii Dermatology Seminar, noting that Cloderm Cream’s molecular design makes it one of only two Class C topical steroids, which rarely cross-react with another steroid, that are available in the United States.

Supporting Studies

The product’s superior safety profile is supported by a clinical study of 147 patients using the treatment for up to 40 days without atrophy, hypopigmentation or striae.

In another study, 38 subjects with a history of sensitization to steroids were given patch-test trials of 10 steroid agents in a petrolatum base, including three formulations of clocortolone pivalate, which remained on the skin initially for 48 hours. Each site was evaluated for the presence of a sensitivity reaction after 48 hours and 96 hours. Results indicated that clocortolone pivalate had the lowest rate of sensitivity reactions at both times.
Further supporting claims about the product were based on a survey of 2,927 dermatologists, 85% of whom reported that the Cloderm Cream vehicle absorbed into the skin very well, and 88% said it had no offensive odor. Lack of tackiness during and after application, as well as non-greasy appearance and feel, were also frequently reported in the survey results.

The most common adverse events with Cloderm Cream included dryness, irritation, folliculitis, acneiform eruptions and burning.
 

Methotrexate Effective and Safe for Children with Severe Atopic Dermatitis

Aposter presented at the winter meeting of the American Academy of Dermatology reported that methotrexate is an effective treatment for children with severe atopic dermatitis.

Noting that research on systemic treatment of children is limited on this most common cause of severe skin disease in children, the investigators retrospectively reviewed data on 30 children with severe atopic dermatitis who had been treated with methotrexate.

Patients ranged in age from 2 to 16 years, and all had failed topical therapy. Many had been treated with cyclosporine and were successfully switched over to methotrexate. All subjects received an initial dose of 0.5 mg/kg/week (maximum 15 mg). Most tolerated the tablet formulation, but among those who received a liquid formulation, it was most often the concentrated 25 mg/cc parenteral formulation.

Supplemental folic acid (1 mg) was added after the first month of treatment and was taken on non-methotrexate days.
Follow-up in the clinic and laboratory assessments took place at baseline and monthly for 3 months, followed every 3 months thereafter if the dosing remained stable. Laboratory parameters included complete blood counts with red blood cell indices and a comprehensive metabolic panel.

Poster authors reported that elevations in hepatic transaminases, which were transient and unusual, were found in blood obtained within 1 to 2 days after methotrexate or after a presumed viral illness. No child underwent liver biopsy.
Dose adjustments occurred every 2 to 3 months as needed.

The investigators found that the majority of methotrexate-treated subjects achieved a partial to complete response, with no serious adverse events occurring among the subjects during an average of 12 months exposure.

Methotrexate for Atopic Dermatitis in Children. Abstract P608.
 

Barrier Therapeutics Posters Support Promising Products for Atopic Diseases

At the winter AAD meeting in San Antonio, Barrier Therapeutics presented findings on promising new treatments for atopic conditions. They included pramiconazole, which is under development for both acute and chronic fungal infections, and of Hivenyl, an antihistamine that may be effective in reducing or eliminating the symptoms of itch without sedating effects.”

The poster presentations were titled:

  • Pramiconazole, a novel oral antifungal agent, effectively treats Pityriasis versicolor — results of a dose finding clinical study; Poster Number: 1704.
  • Oral vapitadine, a new non-sedating antihistamine, relieves itch associated with atopic dermatitis; Poster Number: 601; current product candidate referred to as Hivenyl.

 

 

 

Atopic Dermatitis Increasing in U.S. Children

Agroup of investigators led by Dr. Kimberly A. Horii of Children’s Mercy Hospitals and Clinics in Kansas City, MO, has suggested that atopic dermatitis (AD) among U.S. children is increasing, especially among African-Americans and Asians.

Findings reported in the September issue of Pediatrics (Horii AK. Pediatrics. 2007;120:e527-534.) were based on outpatient encounters compiled from the National Ambulatory Medical Care Survey and The National Hospital Ambulatory Medical Care Survey for 1997 to 2000 and 2001 to 2004.

This increase — gauged by doctor and hospital visits for the condition — was seen among children of all races and ethnic groups, including 620,000 visits in 1997 and a peak of 1.7 million in 2003, which fell to 850,000 in 2004, with patients between ages 2 and 5 presenting at the highest rate (odds ratio 2.4 compared with children ages 11 to 18 years, P=0.001).

Compared with Caucasian patients, the odds ratios were: 1.9 for Hispanics (P=0.02); 2.2 for African-Americans (0.001); and 3.1 for Asians (P=0.001).

Among possible explanations mentioned by the researchers were an awareness of topical calcineurin inhibitors, which debuted during the peak year (2003), as well as improved hygiene, environmental substances, or a higher rate of recognition and diagnosis by physicians.

 

Study Casts Doubt on Benefit of Delayed Introduction of Solid Foods on Atopic Diseases

According to a German study that appeared in Pediatrics (Zutavern A, Brockow I, Schaaf B, et al; LISA Study Group. Pediatrics. 2008 Jan;121(1):e44-52.), it is unlikely that delaying the introduction of solid food beyond 4 to 6 months is protective against the development of eczema, asthma, allergic rhinitis, and food or inhalant sensitization at the age of 6 years.
In fact, the study found that food sensitization was even more frequent among children introduced to solids later.

Method

The prospective birth cohort study LISA utilized data from 2,073 children at 6 years of age. Multivariate logistic regression analyses were performed for all children and for children without skin or allergic symptoms within the first 6 months of life to take into account reverse causality.

Results

While the study found no benefit in relation to AD in delaying solids and, in fact, more frequent food sensitization in that group, it did find that eczema was significantly more frequent in children who received a more diverse diet within the first 4 months.
 

Relationship Between Atopic Disorder and Irritable Bowel Syndrome Studied


A group of investigators from the Department of Immunology/Microbiology at Rush University Medical Center, John H. Stoger, Jr. Hospital in Chicago conducted a study on a possible link between atopic disorders and irritable bowel syndrome (IBS) based on the observation that mast cells have a primary role in atopy.

Methods

A prospective study was designed using structured questionnaires, which were administered to 125 consecutive patients seen in the following clinics from July 1 through October 31, 2001: allergy/immunology (AI) (n=39), gastroenterology (n=36), and general medicine (n=50). The survey included questions detailing gastrointestinal and allergic symptoms. Diagnosis of IBS was based on Rome II criteria. Diagnosis of atopy was based on clinical parameters.

Results

The AI clinic reported a significantly (P = .015) higher rate of IBS than the general medicine clinic, and the IBS incidence reported in the AI clinic was similar to that reported in the gastroenterology clinic. The likelihood of IBS was significantly higher in patients with seasonal allergic rhinitis (2.67 times; 95% confidence interval [CI], 1.10-6.49; P=.03), patients with allergic eczema (3.85 times; 95% CI, 1.72-8.60; P=.001), and patients with depression (2.56 times; 95% CI, 1.05-6.14; P=.04). Patients reporting atopic symptoms (seasonal allergic rhinitis, allergic eczema, and asthma) were 3.20 times (95% CI, 1.20-8.50) (P=.02) more likely to fulfill the criteria for IBS.

Higher Incidence of IBS

Authors concluded that adults with atopic symptoms do in fact report a high incidence of IBS, suggesting a link between atopy and IBS. They further suggested that being able to establish a subgroup of atopic IBS patient vs. nonatopic IBS may help in identifying the underlying pathophysiologic mechanisms involved and therapeutic options.

Tobin MC, Moparty B, Farhadi A, DeMeo MT, Bansal PJ, Keshavarzian A. Atopic irritable bowel syndrome: a novel subgroup of irritable bowel syndrome with allergic manifestations. Ann Allergy Asthma Immunol. 2008 Jan;100(1):49-53.
 

Study Suggests Association Between Bacterium and Atopic Eczema

Bifidobacterium pseudocatenulatum, which is commonly found in the fecal microflora of infants — particularly those who are not breast fed — was found to be associated with atopic eczema, and may therefore be a biomarker for susceptibility to this atopic disease, according to Dr. Gerald W. Tannock, of the University of Otago, Dunedin, New Zealand, and colleagues who reported their findings in Journal of Allergy and Clinical Immunology. (J Allergy Clin Immunol. 2008;121:135-140.)

Study

In a nested case-control study, the researchers compared fecal bacterial communities of 37 infants 3 to 6 months of age with that of 24 infants without eczema who were matched for sex, age, feeding method, weaning, and ethnicity. They also collected information on maternal and infant antibiotic exposure, feeding, gastrointestinal symptoms, and family history of allergy.

Findings

While no significant differences in overall profiles of fecal bacterial communities were observed between cases and controls, infants with a family history of allergic disease were significantly more likely to have bifidobacteria in their feces than those without a family history (86% vs. 58%; P=0.05), as were those who were not breast fed (39% vs. 9%; P=0.01). The increased risk was confirmed in logistic regression analysis (odds ratio, 5.6; P=0.02).

B. pseudocatenulatum was also detected more commonly in children with eczema than in those without eczema (27% vs. 4%; P=0.04).
 

Cloderm Found Safest for Atopic Dermatitis

According to Dr. Matthew Zirwas, Director of the Ohio State University Contact and Occupational Dermatology Center and member of the Coria Laboratories speaker panel, the mid-potency steroid cream clocortolone pivalate (Cloderm Cream, 0.1%), has been established as an appropriate short-term therapy for dermatitis, and is the one with the lowest potential to cause an allergic reaction on the skin or to have a cross-reaction with other steroids. Cloderm Cream was said to be highly effective in treating all patients with many forms of dermatosis, including contact dermatitis, atopic dermatitis, seborrheic dermatitis, stasis dermatitis and psoriasis vulgaris.

Dr. Matthew Zirwas made these claims during the annual Hawaii Dermatology Seminar, noting that Cloderm Cream’s molecular design makes it one of only two Class C topical steroids, which rarely cross-react with another steroid, that are available in the United States.

Supporting Studies

The product’s superior safety profile is supported by a clinical study of 147 patients using the treatment for up to 40 days without atrophy, hypopigmentation or striae.

In another study, 38 subjects with a history of sensitization to steroids were given patch-test trials of 10 steroid agents in a petrolatum base, including three formulations of clocortolone pivalate, which remained on the skin initially for 48 hours. Each site was evaluated for the presence of a sensitivity reaction after 48 hours and 96 hours. Results indicated that clocortolone pivalate had the lowest rate of sensitivity reactions at both times.
Further supporting claims about the product were based on a survey of 2,927 dermatologists, 85% of whom reported that the Cloderm Cream vehicle absorbed into the skin very well, and 88% said it had no offensive odor. Lack of tackiness during and after application, as well as non-greasy appearance and feel, were also frequently reported in the survey results.

The most common adverse events with Cloderm Cream included dryness, irritation, folliculitis, acneiform eruptions and burning.
 

Methotrexate Effective and Safe for Children with Severe Atopic Dermatitis

Aposter presented at the winter meeting of the American Academy of Dermatology reported that methotrexate is an effective treatment for children with severe atopic dermatitis.

Noting that research on systemic treatment of children is limited on this most common cause of severe skin disease in children, the investigators retrospectively reviewed data on 30 children with severe atopic dermatitis who had been treated with methotrexate.

Patients ranged in age from 2 to 16 years, and all had failed topical therapy. Many had been treated with cyclosporine and were successfully switched over to methotrexate. All subjects received an initial dose of 0.5 mg/kg/week (maximum 15 mg). Most tolerated the tablet formulation, but among those who received a liquid formulation, it was most often the concentrated 25 mg/cc parenteral formulation.

Supplemental folic acid (1 mg) was added after the first month of treatment and was taken on non-methotrexate days.
Follow-up in the clinic and laboratory assessments took place at baseline and monthly for 3 months, followed every 3 months thereafter if the dosing remained stable. Laboratory parameters included complete blood counts with red blood cell indices and a comprehensive metabolic panel.

Poster authors reported that elevations in hepatic transaminases, which were transient and unusual, were found in blood obtained within 1 to 2 days after methotrexate or after a presumed viral illness. No child underwent liver biopsy.
Dose adjustments occurred every 2 to 3 months as needed.

The investigators found that the majority of methotrexate-treated subjects achieved a partial to complete response, with no serious adverse events occurring among the subjects during an average of 12 months exposure.

Methotrexate for Atopic Dermatitis in Children. Abstract P608.
 

Barrier Therapeutics Posters Support Promising Products for Atopic Diseases

At the winter AAD meeting in San Antonio, Barrier Therapeutics presented findings on promising new treatments for atopic conditions. They included pramiconazole, which is under development for both acute and chronic fungal infections, and of Hivenyl, an antihistamine that may be effective in reducing or eliminating the symptoms of itch without sedating effects.”

The poster presentations were titled:

  • Pramiconazole, a novel oral antifungal agent, effectively treats Pityriasis versicolor — results of a dose finding clinical study; Poster Number: 1704.
  • Oral vapitadine, a new non-sedating antihistamine, relieves itch associated with atopic dermatitis; Poster Number: 601; current product candidate referred to as Hivenyl.