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New one-time treatment for head lice found safe for children
CHICAGO – A novel one-time topical treatment for head lice, abametapir, was well tolerated in children as young as 6 months, according to pooled results from 11 clinical trials.
The pooled safety data included results from 11 clinical trials including 1,372 patients. Of these, 700 were aged 6 months to 17 years, and patients were exposed to the novel metalloproteinase inhibitor for 10-20 minutes.
In examining safety data from the pooled trials, Lydie Hazan, MD, of Axis Clinical Trials and her collaborators found that for pediatric patients, most treatment-emergent adverse events (AEs) were skin and subcutaneous tissue-related. The most common AEs were erythema, rash, a burning sensation on the skin, and contact dermatitis.
Data for the three phase II pharmacokinetic trials, the phase II ovicidal efficacy trial, and the two phase III trials were reported separately by Dr. Hazan and her coauthors in a poster presentation at the World Congress of Pediatric Dermatology. The overall incidence of treatment-emergent AEs in the studies ranged from 20% to 29% for patients in the active arms of the trials. For patients who received the vehicle lotion only, the incidence of AEs ranged from 16% to 57%.
Of the 11 trials, 6 involved pediatric patients, with one phase IIB trial, one phase II ovicidal trial, two maximal-use open-label trials, and two phase III randomized, double-blind, vehicle-controlled trials. Of the 920 patients, in most of the trials they received a 10-minute exposure to the study drug (489 received abametapir lotion 0.74%, 431 received vehicle lotion).
Looking just at the phase III trials, 24% of patients in the abametapir arm reported AEs, while 19% of those receiving vehicle reported any AE.
In the two maximal-use pediatric trials, drug exposure ranged from 3.3 g to 200.8 g; AEs in these two trials occurred in 23% of participants.
Safety data collected for all studies also included vital signs, results of physical exams, and laboratory tests; no “clinically meaningful” changes were seen in any of the trials for any of these values, according to Dr. Hazan and her coauthors.
“AEs were mild, not age-related, and primarily in the system organ class of skin and subcutaneous tissue disorders,” said Dr. Hazan and her coauthors.
Abematapir 0.74% lotion had previously been shown to be an effective ovicidal treatment for head lice when used in a single application; the lotion is intended to be applied at home by the patient or caregiver (J Med Entomol. 2017. 54[1]:167-72).*
Dr. Hazan is employed by Axis clinical trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
*Correction, 8/7/17: An earlier version of this article had an incorrect citation.
koakes@frontlinemedcom.com
On Twitter @karioakes
CHICAGO – A novel one-time topical treatment for head lice, abametapir, was well tolerated in children as young as 6 months, according to pooled results from 11 clinical trials.
The pooled safety data included results from 11 clinical trials including 1,372 patients. Of these, 700 were aged 6 months to 17 years, and patients were exposed to the novel metalloproteinase inhibitor for 10-20 minutes.
In examining safety data from the pooled trials, Lydie Hazan, MD, of Axis Clinical Trials and her collaborators found that for pediatric patients, most treatment-emergent adverse events (AEs) were skin and subcutaneous tissue-related. The most common AEs were erythema, rash, a burning sensation on the skin, and contact dermatitis.
Data for the three phase II pharmacokinetic trials, the phase II ovicidal efficacy trial, and the two phase III trials were reported separately by Dr. Hazan and her coauthors in a poster presentation at the World Congress of Pediatric Dermatology. The overall incidence of treatment-emergent AEs in the studies ranged from 20% to 29% for patients in the active arms of the trials. For patients who received the vehicle lotion only, the incidence of AEs ranged from 16% to 57%.
Of the 11 trials, 6 involved pediatric patients, with one phase IIB trial, one phase II ovicidal trial, two maximal-use open-label trials, and two phase III randomized, double-blind, vehicle-controlled trials. Of the 920 patients, in most of the trials they received a 10-minute exposure to the study drug (489 received abametapir lotion 0.74%, 431 received vehicle lotion).
Looking just at the phase III trials, 24% of patients in the abametapir arm reported AEs, while 19% of those receiving vehicle reported any AE.
In the two maximal-use pediatric trials, drug exposure ranged from 3.3 g to 200.8 g; AEs in these two trials occurred in 23% of participants.
Safety data collected for all studies also included vital signs, results of physical exams, and laboratory tests; no “clinically meaningful” changes were seen in any of the trials for any of these values, according to Dr. Hazan and her coauthors.
“AEs were mild, not age-related, and primarily in the system organ class of skin and subcutaneous tissue disorders,” said Dr. Hazan and her coauthors.
Abematapir 0.74% lotion had previously been shown to be an effective ovicidal treatment for head lice when used in a single application; the lotion is intended to be applied at home by the patient or caregiver (J Med Entomol. 2017. 54[1]:167-72).*
Dr. Hazan is employed by Axis clinical trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
*Correction, 8/7/17: An earlier version of this article had an incorrect citation.
koakes@frontlinemedcom.com
On Twitter @karioakes
CHICAGO – A novel one-time topical treatment for head lice, abametapir, was well tolerated in children as young as 6 months, according to pooled results from 11 clinical trials.
The pooled safety data included results from 11 clinical trials including 1,372 patients. Of these, 700 were aged 6 months to 17 years, and patients were exposed to the novel metalloproteinase inhibitor for 10-20 minutes.
In examining safety data from the pooled trials, Lydie Hazan, MD, of Axis Clinical Trials and her collaborators found that for pediatric patients, most treatment-emergent adverse events (AEs) were skin and subcutaneous tissue-related. The most common AEs were erythema, rash, a burning sensation on the skin, and contact dermatitis.
Data for the three phase II pharmacokinetic trials, the phase II ovicidal efficacy trial, and the two phase III trials were reported separately by Dr. Hazan and her coauthors in a poster presentation at the World Congress of Pediatric Dermatology. The overall incidence of treatment-emergent AEs in the studies ranged from 20% to 29% for patients in the active arms of the trials. For patients who received the vehicle lotion only, the incidence of AEs ranged from 16% to 57%.
Of the 11 trials, 6 involved pediatric patients, with one phase IIB trial, one phase II ovicidal trial, two maximal-use open-label trials, and two phase III randomized, double-blind, vehicle-controlled trials. Of the 920 patients, in most of the trials they received a 10-minute exposure to the study drug (489 received abametapir lotion 0.74%, 431 received vehicle lotion).
Looking just at the phase III trials, 24% of patients in the abametapir arm reported AEs, while 19% of those receiving vehicle reported any AE.
In the two maximal-use pediatric trials, drug exposure ranged from 3.3 g to 200.8 g; AEs in these two trials occurred in 23% of participants.
Safety data collected for all studies also included vital signs, results of physical exams, and laboratory tests; no “clinically meaningful” changes were seen in any of the trials for any of these values, according to Dr. Hazan and her coauthors.
“AEs were mild, not age-related, and primarily in the system organ class of skin and subcutaneous tissue disorders,” said Dr. Hazan and her coauthors.
Abematapir 0.74% lotion had previously been shown to be an effective ovicidal treatment for head lice when used in a single application; the lotion is intended to be applied at home by the patient or caregiver (J Med Entomol. 2017. 54[1]:167-72).*
Dr. Hazan is employed by Axis clinical trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
*Correction, 8/7/17: An earlier version of this article had an incorrect citation.
koakes@frontlinemedcom.com
On Twitter @karioakes
AT WCPD 2017
Key clinical point:
Major finding: In pooled clinical trial data, pediatric patients had adverse events at the same rate as adult patients, with overall rates ranging from 20% to 57%.
Data source: Pooled data from 11 clinical trials including 1,372 patients, 700 of whom were aged 6 months to 17 years.
Disclosures: Dr. Hazan is employed by Axis Clinical Trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
Look for comorbidities associated with hidradenitis suppurativa
CHICAGO – Hidradenitis suppurativa in children is often associated with comorbidities, especially obesity and endocrine abnormalities, a retrospective review of cases showed.
“When treating hidradenitis suppurativa, it is imperative to not only treat the skin but also to look for associated comorbidities,” Maria del Carmen Liy-Wong, MD, said in an interview in advance of the World Congress for Pediatric Dermatology.
Of the 41 patients, 78% were girls; the mean age of onset was 11 years, and the mean age at diagnosis was 14 years. A positive family history was found in 24% of cases. The most common cutaneous lesions were papules and pustules (51%), followed by scars (39%), and 88% of patients reported associated tenderness and pain.
After using the Hurley severity grade to classify disease severity, the researchers found that 56% of cases were mild, 32% were moderate, and 12% were severe. Comorbidities were identified in 92% of the cases; the most common was obesity (73%), followed by endocrine abnormalities (29%) and menstrual irregularities (20%). The researchers also found that 70% of patients were treated with a combination of topical and systemic antibiotics, and that early onset of disease correlated with more severe disease (P = .03).
Dr. Liy-Wong acknowledged that the study’s retrospective design is a limitation of the analysis, but she said that a prospective evaluation in planned for the near future.
The study was supported in part by a grant from AbbVie. Dr. Liy-Wong reported having no relevant financial disclosures.
dbrunk@frontlinemedcom.com
CHICAGO – Hidradenitis suppurativa in children is often associated with comorbidities, especially obesity and endocrine abnormalities, a retrospective review of cases showed.
“When treating hidradenitis suppurativa, it is imperative to not only treat the skin but also to look for associated comorbidities,” Maria del Carmen Liy-Wong, MD, said in an interview in advance of the World Congress for Pediatric Dermatology.
Of the 41 patients, 78% were girls; the mean age of onset was 11 years, and the mean age at diagnosis was 14 years. A positive family history was found in 24% of cases. The most common cutaneous lesions were papules and pustules (51%), followed by scars (39%), and 88% of patients reported associated tenderness and pain.
After using the Hurley severity grade to classify disease severity, the researchers found that 56% of cases were mild, 32% were moderate, and 12% were severe. Comorbidities were identified in 92% of the cases; the most common was obesity (73%), followed by endocrine abnormalities (29%) and menstrual irregularities (20%). The researchers also found that 70% of patients were treated with a combination of topical and systemic antibiotics, and that early onset of disease correlated with more severe disease (P = .03).
Dr. Liy-Wong acknowledged that the study’s retrospective design is a limitation of the analysis, but she said that a prospective evaluation in planned for the near future.
The study was supported in part by a grant from AbbVie. Dr. Liy-Wong reported having no relevant financial disclosures.
dbrunk@frontlinemedcom.com
CHICAGO – Hidradenitis suppurativa in children is often associated with comorbidities, especially obesity and endocrine abnormalities, a retrospective review of cases showed.
“When treating hidradenitis suppurativa, it is imperative to not only treat the skin but also to look for associated comorbidities,” Maria del Carmen Liy-Wong, MD, said in an interview in advance of the World Congress for Pediatric Dermatology.
Of the 41 patients, 78% were girls; the mean age of onset was 11 years, and the mean age at diagnosis was 14 years. A positive family history was found in 24% of cases. The most common cutaneous lesions were papules and pustules (51%), followed by scars (39%), and 88% of patients reported associated tenderness and pain.
After using the Hurley severity grade to classify disease severity, the researchers found that 56% of cases were mild, 32% were moderate, and 12% were severe. Comorbidities were identified in 92% of the cases; the most common was obesity (73%), followed by endocrine abnormalities (29%) and menstrual irregularities (20%). The researchers also found that 70% of patients were treated with a combination of topical and systemic antibiotics, and that early onset of disease correlated with more severe disease (P = .03).
Dr. Liy-Wong acknowledged that the study’s retrospective design is a limitation of the analysis, but she said that a prospective evaluation in planned for the near future.
The study was supported in part by a grant from AbbVie. Dr. Liy-Wong reported having no relevant financial disclosures.
dbrunk@frontlinemedcom.com
AT WCPD 2017
Key clinical point:
Major finding: Comorbidities were identified in 92% of the cases, with obesity (73%) the most common.
Data source: A retrospective review of clinical characteristics, degree of severity, comorbidities, and management of hidradenitis suppurativa in 41 patients followed between January 1995 and January 2015.
Disclosures: Dr. Liy-Wong reported having no relevant financial disclosures.