EpiCeram Combo Tx Shows Benefit for Atopic Dermatitis

PORTLAND, Ore. – Approximately half of 207 patients with mild to moderate atopic dermatitis were clear or almost clear of disease after using EpiCeram skin barrier emulsion for 3 weeks, either alone or in combination with treatment, according to a report of an open-label study.

At the end of 3 weeks, the mean atopic dermatitis (AD) investigator global assessment (IGA) score improved from a baseline of 2.50 on a 5-point scale to 1.47. The mean pruritus score improved from 2.35 to 1.46 on a 5-point scale.

At week 3 after applying the emulsion twice daily to affected sites, 62% of subjects with baseline mild disease (defined as an IGA score of 2) were rated on the IGA scale as clear (a score of 0) or almost clear (a score of 1); 46% of those with moderate disease (an IGA score of 3 at baseline) were rated as clear or almost clear at the end of the study, said Dr. Leon Kircik, a dermatologist at Indiana University Medical Center, Bloomington, and his associates.

When Promius Pharma LLC’s EpiCeram skin barrier emulsion was used alone, 56% of subjects had clear or almost clear IGA scores at the end of week 3; 48% achieved those results when it was used in combination, usually with topical corticosteroids.

The study, not yet published, does not analyze who in the disease severity subgroups improved using EpiCeram alone, and who improved when it was used in combination. The trial had no placebo group.

Results were similar for the 59 pediatric patients in the trial (age range, 1 month–16 years), according to a subgroup analysis presented in poster form by Dr. Kircik at the annual meeting of the Society for Pediatric Dermatology.

At the end of 3 weeks, 62% of EpiCeram monotherapy pediatric patients had clear or almost clear IGA scores; 50% who used EpiCeram in combination with another treatment achieved those results. Pruritus scores were roughly halved among pediatric patients overall, said Dr. Kircik.

The study proved EpiCeram “to be an effective and versatile agent that can be used with or without additional AD therapy to provide good clinical efficacy and high levels of investigator and patient satisfaction,” said Dr. Kircik.

EpiCeram emulsion contains ceramide, cholesterol, and free fatty acids in a molar ratio of 3:1:1. It was cleared for marketing by the Food and Drug Administration in 2006.

Subjects in the trial were recruited from 50 dermatology practices across the country; 49% were assessed by investigators to have mild disease at baseline, 51% moderate disease; 81% reported one or more AD flares per month at baseline.

All subjects were EpiCeram naive. Their mean age was 34 years, and 65% were women, the majority white. The median duration of AD diagnosis was 5 years.

At baseline, current AD medications were stopped and subjects were given EpiCeram along with an add-on prescription, selected at the discretion of their dermatologist-investigator, to use if their AD worsened. Most prescriptions were for topical corticosteroids; three were for Protopic (tacrolimus), and two for an oral antihistamine, according to the report.

Subjects were instructed to apply EpiCeram to affected areas, as well as to antecubital, popliteal, or other predisposed regions, approximately every 12 hours.

At assessment 3 weeks later, 71% of subjects reported using EpiCeram every day, 22% “most every day,” and 7% occasionally; 29% used the additional medication.

The report does not break-down efficacy results by reported usage.

Six subjects reported a total of seven adverse events, including erythema, skin irritation, pruritus, paresthesia, and pain. An additional nine subjects reported worsening AD.

EpiCeram’s effects satisfied 75% of subjects and 77% of investigators; 78% of subjects believed that their AD had improved, at least a little, since baseline, according to the report.

“In this study, it seems that clinical efficacy alone did not contribute to satisfaction, as rates of satisfaction were higher than the rate for clinical success,” the authors noted.

When Dr. Eric Simpson, a dermatologist and AD expert from the Oregon Health and Science University in Portland, was asked to comment on the study, he said, “I think some people with mild to moderate disease can improve with EpiCeram, but it is difficult to draw conclusions without a vehicle control.”

He noted that 20%-25% of AD patients in placebo-controlled trials improve with just vehicle alone. Given the response rates in the EpiCeram trial, “I think these people probably did get better. The question is if they would have gotten better with moisturizer alone.”

Dr. Simpson said he is likely to try EpiCeram when he can’t use the calcineurin inhibitors Protopic or Elidel (pimecrolimus) because these agents burn patients too much on application, if a patient has skin cancer, or for some other reason. Such situations give him “a good opportunity to try it,” he said.

The study was funded by EpiCeram’s distributor, Promius Pharma LLC. Dr. Kircik and his associate Dr. Del Rosso are consultants and speakers for Promius Pharma. Dr. Kircik’s associate Daniel Aversa is a Promius Pharma employee. Dr. Simpson disclosed that he participated in research funded by Ceragenix Pharmaceuticals Inc., the original developer of EpiCeram.

PORTLAND, Ore. – Approximately half of 207 patients with mild to moderate atopic dermatitis were clear or almost clear of disease after using EpiCeram skin barrier emulsion for 3 weeks, either alone or in combination with treatment, according to a report of an open-label study.

At the end of 3 weeks, the mean atopic dermatitis (AD) investigator global assessment (IGA) score improved from a baseline of 2.50 on a 5-point scale to 1.47. The mean pruritus score improved from 2.35 to 1.46 on a 5-point scale.

At week 3 after applying the emulsion twice daily to affected sites, 62% of subjects with baseline mild disease (defined as an IGA score of 2) were rated on the IGA scale as clear (a score of 0) or almost clear (a score of 1); 46% of those with moderate disease (an IGA score of 3 at baseline) were rated as clear or almost clear at the end of the study, said Dr. Leon Kircik, a dermatologist at Indiana University Medical Center, Bloomington, and his associates.

When Promius Pharma LLC’s EpiCeram skin barrier emulsion was used alone, 56% of subjects had clear or almost clear IGA scores at the end of week 3; 48% achieved those results when it was used in combination, usually with topical corticosteroids.

The study, not yet published, does not analyze who in the disease severity subgroups improved using EpiCeram alone, and who improved when it was used in combination. The trial had no placebo group.

Results were similar for the 59 pediatric patients in the trial (age range, 1 month–16 years), according to a subgroup analysis presented in poster form by Dr. Kircik at the annual meeting of the Society for Pediatric Dermatology.

At the end of 3 weeks, 62% of EpiCeram monotherapy pediatric patients had clear or almost clear IGA scores; 50% who used EpiCeram in combination with another treatment achieved those results. Pruritus scores were roughly halved among pediatric patients overall, said Dr. Kircik.

The study proved EpiCeram “to be an effective and versatile agent that can be used with or without additional AD therapy to provide good clinical efficacy and high levels of investigator and patient satisfaction,” said Dr. Kircik.

EpiCeram emulsion contains ceramide, cholesterol, and free fatty acids in a molar ratio of 3:1:1. It was cleared for marketing by the Food and Drug Administration in 2006.

Subjects in the trial were recruited from 50 dermatology practices across the country; 49% were assessed by investigators to have mild disease at baseline, 51% moderate disease; 81% reported one or more AD flares per month at baseline.

All subjects were EpiCeram naive. Their mean age was 34 years, and 65% were women, the majority white. The median duration of AD diagnosis was 5 years.

At baseline, current AD medications were stopped and subjects were given EpiCeram along with an add-on prescription, selected at the discretion of their dermatologist-investigator, to use if their AD worsened. Most prescriptions were for topical corticosteroids; three were for Protopic (tacrolimus), and two for an oral antihistamine, according to the report.

Subjects were instructed to apply EpiCeram to affected areas, as well as to antecubital, popliteal, or other predisposed regions, approximately every 12 hours.

At assessment 3 weeks later, 71% of subjects reported using EpiCeram every day, 22% “most every day,” and 7% occasionally; 29% used the additional medication.

The report does not break-down efficacy results by reported usage.

Six subjects reported a total of seven adverse events, including erythema, skin irritation, pruritus, paresthesia, and pain. An additional nine subjects reported worsening AD.

EpiCeram’s effects satisfied 75% of subjects and 77% of investigators; 78% of subjects believed that their AD had improved, at least a little, since baseline, according to the report.

“In this study, it seems that clinical efficacy alone did not contribute to satisfaction, as rates of satisfaction were higher than the rate for clinical success,” the authors noted.

When Dr. Eric Simpson, a dermatologist and AD expert from the Oregon Health and Science University in Portland, was asked to comment on the study, he said, “I think some people with mild to moderate disease can improve with EpiCeram, but it is difficult to draw conclusions without a vehicle control.”

He noted that 20%-25% of AD patients in placebo-controlled trials improve with just vehicle alone. Given the response rates in the EpiCeram trial, “I think these people probably did get better. The question is if they would have gotten better with moisturizer alone.”

Dr. Simpson said he is likely to try EpiCeram when he can’t use the calcineurin inhibitors Protopic or Elidel (pimecrolimus) because these agents burn patients too much on application, if a patient has skin cancer, or for some other reason. Such situations give him “a good opportunity to try it,” he said.

The study was funded by EpiCeram’s distributor, Promius Pharma LLC. Dr. Kircik and his associate Dr. Del Rosso are consultants and speakers for Promius Pharma. Dr. Kircik’s associate Daniel Aversa is a Promius Pharma employee. Dr. Simpson disclosed that he participated in research funded by Ceragenix Pharmaceuticals Inc., the original developer of EpiCeram.

PORTLAND, Ore. – Approximately half of 207 patients with mild to moderate atopic dermatitis were clear or almost clear of disease after using EpiCeram skin barrier emulsion for 3 weeks, either alone or in combination with treatment, according to a report of an open-label study.

At the end of 3 weeks, the mean atopic dermatitis (AD) investigator global assessment (IGA) score improved from a baseline of 2.50 on a 5-point scale to 1.47. The mean pruritus score improved from 2.35 to 1.46 on a 5-point scale.

At week 3 after applying the emulsion twice daily to affected sites, 62% of subjects with baseline mild disease (defined as an IGA score of 2) were rated on the IGA scale as clear (a score of 0) or almost clear (a score of 1); 46% of those with moderate disease (an IGA score of 3 at baseline) were rated as clear or almost clear at the end of the study, said Dr. Leon Kircik, a dermatologist at Indiana University Medical Center, Bloomington, and his associates.

When Promius Pharma LLC’s EpiCeram skin barrier emulsion was used alone, 56% of subjects had clear or almost clear IGA scores at the end of week 3; 48% achieved those results when it was used in combination, usually with topical corticosteroids.

The study, not yet published, does not analyze who in the disease severity subgroups improved using EpiCeram alone, and who improved when it was used in combination. The trial had no placebo group.

Results were similar for the 59 pediatric patients in the trial (age range, 1 month–16 years), according to a subgroup analysis presented in poster form by Dr. Kircik at the annual meeting of the Society for Pediatric Dermatology.

At the end of 3 weeks, 62% of EpiCeram monotherapy pediatric patients had clear or almost clear IGA scores; 50% who used EpiCeram in combination with another treatment achieved those results. Pruritus scores were roughly halved among pediatric patients overall, said Dr. Kircik.

The study proved EpiCeram “to be an effective and versatile agent that can be used with or without additional AD therapy to provide good clinical efficacy and high levels of investigator and patient satisfaction,” said Dr. Kircik.

EpiCeram emulsion contains ceramide, cholesterol, and free fatty acids in a molar ratio of 3:1:1. It was cleared for marketing by the Food and Drug Administration in 2006.

Subjects in the trial were recruited from 50 dermatology practices across the country; 49% were assessed by investigators to have mild disease at baseline, 51% moderate disease; 81% reported one or more AD flares per month at baseline.

All subjects were EpiCeram naive. Their mean age was 34 years, and 65% were women, the majority white. The median duration of AD diagnosis was 5 years.

At baseline, current AD medications were stopped and subjects were given EpiCeram along with an add-on prescription, selected at the discretion of their dermatologist-investigator, to use if their AD worsened. Most prescriptions were for topical corticosteroids; three were for Protopic (tacrolimus), and two for an oral antihistamine, according to the report.

Subjects were instructed to apply EpiCeram to affected areas, as well as to antecubital, popliteal, or other predisposed regions, approximately every 12 hours.

At assessment 3 weeks later, 71% of subjects reported using EpiCeram every day, 22% “most every day,” and 7% occasionally; 29% used the additional medication.

The report does not break-down efficacy results by reported usage.

Six subjects reported a total of seven adverse events, including erythema, skin irritation, pruritus, paresthesia, and pain. An additional nine subjects reported worsening AD.

EpiCeram’s effects satisfied 75% of subjects and 77% of investigators; 78% of subjects believed that their AD had improved, at least a little, since baseline, according to the report.

“In this study, it seems that clinical efficacy alone did not contribute to satisfaction, as rates of satisfaction were higher than the rate for clinical success,” the authors noted.

When Dr. Eric Simpson, a dermatologist and AD expert from the Oregon Health and Science University in Portland, was asked to comment on the study, he said, “I think some people with mild to moderate disease can improve with EpiCeram, but it is difficult to draw conclusions without a vehicle control.”

He noted that 20%-25% of AD patients in placebo-controlled trials improve with just vehicle alone. Given the response rates in the EpiCeram trial, “I think these people probably did get better. The question is if they would have gotten better with moisturizer alone.”

Dr. Simpson said he is likely to try EpiCeram when he can’t use the calcineurin inhibitors Protopic or Elidel (pimecrolimus) because these agents burn patients too much on application, if a patient has skin cancer, or for some other reason. Such situations give him “a good opportunity to try it,” he said.

The study was funded by EpiCeram’s distributor, Promius Pharma LLC. Dr. Kircik and his associate Dr. Del Rosso are consultants and speakers for Promius Pharma. Dr. Kircik’s associate Daniel Aversa is a Promius Pharma employee. Dr. Simpson disclosed that he participated in research funded by Ceragenix Pharmaceuticals Inc., the original developer of EpiCeram.