Desonide Foam Improves Atopic Pruritus

PHILADELPHIA — Desonide emulsion foam significantly reduced pruritus among pediatric patients with moderate atopic dermatitis compared with the vehicle alone, according to the results of a randomized phase III study of more than 500 children and adolescents.

At week 4, 34% of patients in the desonide group had a pruritus score of 0 (no pruritus), compared with 9% in the vehicle group, Dr. Sheila F. Friedlander and her colleagues reported in a poster presented at the annual meeting of the Society for Pediatric Dermatology.

Desonide is a low-potency corticosteroid approved in the United States for the treatment of corticosteroid-responsive dermatoses. Ethanol-free desonide emulsion foam (Verdeso), developed by Connetics Corporation, is approved to treat mild-to-moderate atopic dermatitis (AD). The company funded this study, said Dr. Friedlander, a professor of pediatrics and medicine (dermatology) at the University of California, San Diego.

The multicenter trial included patients at least 3 months old but less than 18 years with moderate AD. Patients were assigned to age-based cohorts: 12 years to less than 18 years (cohort 1), 6 years to less than 12 years (cohort 2), 3 years to less than 6 years (cohort 3), and 3 months to less than 3 years (cohort 4).

In all, 581 patients were included in the study—387 in the desonide group and 194 in the vehicle group. The majority of patients (87%) completed the planned 4-week treatment period—93% of the desonide group and 77% of the vehicle group. There were no differences between the two groups in terms of baseline pruritus scores.

Patients or primary caregivers were instructed to apply the foam twice daily (mornings and evenings) to affected areas over a 4-week period. They were instructed to include the face and other thin-skinned areas, if affected. Efficacy was assessed during scheduled visits at baseline (day 1), week 2, week 4 (or end of treatment), and 3 weeks after the end of treatment.

Patients and/or caregivers were instructed to assess pruritus for 24 hours prior to each study visit, using a pruritus score table. The investigators did not assess pruritus. Patients who were not able to read and/or understand the score table had their pruritus scored by investigator interview. Pruritus was scored 0–4, with a score of 0 meaning no itching and a score of 4 meaning severe/constant itching (disrupting sleep and activities).

In addition, patients or caregivers completed the Dermatology Life Quality Index (DLQI) or the Children's Dermatology Life Quality Index questionnaire at baseline and again at week 4.

Patients in the desonide group had significantly decreased mean pruritus at week 2 and week 4 compared with those in the vehicle group. Importantly, no rebound phenomenon was observed 3 weeks after the end of treatment for either group. The average pruritus scores at weeks 2 and 4 did not vary by age cohort.

The average quality of life measure was significantly improved for the patients on desonide compared with those on vehicle alone at week 4.

Dr. Friedlander disclosed that she has received grants for educational activities from Connetics and several other pharmaceutical companies.

PHILADELPHIA — Desonide emulsion foam significantly reduced pruritus among pediatric patients with moderate atopic dermatitis compared with the vehicle alone, according to the results of a randomized phase III study of more than 500 children and adolescents.

At week 4, 34% of patients in the desonide group had a pruritus score of 0 (no pruritus), compared with 9% in the vehicle group, Dr. Sheila F. Friedlander and her colleagues reported in a poster presented at the annual meeting of the Society for Pediatric Dermatology.

Desonide is a low-potency corticosteroid approved in the United States for the treatment of corticosteroid-responsive dermatoses. Ethanol-free desonide emulsion foam (Verdeso), developed by Connetics Corporation, is approved to treat mild-to-moderate atopic dermatitis (AD). The company funded this study, said Dr. Friedlander, a professor of pediatrics and medicine (dermatology) at the University of California, San Diego.

The multicenter trial included patients at least 3 months old but less than 18 years with moderate AD. Patients were assigned to age-based cohorts: 12 years to less than 18 years (cohort 1), 6 years to less than 12 years (cohort 2), 3 years to less than 6 years (cohort 3), and 3 months to less than 3 years (cohort 4).

In all, 581 patients were included in the study—387 in the desonide group and 194 in the vehicle group. The majority of patients (87%) completed the planned 4-week treatment period—93% of the desonide group and 77% of the vehicle group. There were no differences between the two groups in terms of baseline pruritus scores.

Patients or primary caregivers were instructed to apply the foam twice daily (mornings and evenings) to affected areas over a 4-week period. They were instructed to include the face and other thin-skinned areas, if affected. Efficacy was assessed during scheduled visits at baseline (day 1), week 2, week 4 (or end of treatment), and 3 weeks after the end of treatment.

Patients and/or caregivers were instructed to assess pruritus for 24 hours prior to each study visit, using a pruritus score table. The investigators did not assess pruritus. Patients who were not able to read and/or understand the score table had their pruritus scored by investigator interview. Pruritus was scored 0–4, with a score of 0 meaning no itching and a score of 4 meaning severe/constant itching (disrupting sleep and activities).

In addition, patients or caregivers completed the Dermatology Life Quality Index (DLQI) or the Children's Dermatology Life Quality Index questionnaire at baseline and again at week 4.

Patients in the desonide group had significantly decreased mean pruritus at week 2 and week 4 compared with those in the vehicle group. Importantly, no rebound phenomenon was observed 3 weeks after the end of treatment for either group. The average pruritus scores at weeks 2 and 4 did not vary by age cohort.

The average quality of life measure was significantly improved for the patients on desonide compared with those on vehicle alone at week 4.

Dr. Friedlander disclosed that she has received grants for educational activities from Connetics and several other pharmaceutical companies.

PHILADELPHIA — Desonide emulsion foam significantly reduced pruritus among pediatric patients with moderate atopic dermatitis compared with the vehicle alone, according to the results of a randomized phase III study of more than 500 children and adolescents.

At week 4, 34% of patients in the desonide group had a pruritus score of 0 (no pruritus), compared with 9% in the vehicle group, Dr. Sheila F. Friedlander and her colleagues reported in a poster presented at the annual meeting of the Society for Pediatric Dermatology.

Desonide is a low-potency corticosteroid approved in the United States for the treatment of corticosteroid-responsive dermatoses. Ethanol-free desonide emulsion foam (Verdeso), developed by Connetics Corporation, is approved to treat mild-to-moderate atopic dermatitis (AD). The company funded this study, said Dr. Friedlander, a professor of pediatrics and medicine (dermatology) at the University of California, San Diego.

The multicenter trial included patients at least 3 months old but less than 18 years with moderate AD. Patients were assigned to age-based cohorts: 12 years to less than 18 years (cohort 1), 6 years to less than 12 years (cohort 2), 3 years to less than 6 years (cohort 3), and 3 months to less than 3 years (cohort 4).

In all, 581 patients were included in the study—387 in the desonide group and 194 in the vehicle group. The majority of patients (87%) completed the planned 4-week treatment period—93% of the desonide group and 77% of the vehicle group. There were no differences between the two groups in terms of baseline pruritus scores.

Patients or primary caregivers were instructed to apply the foam twice daily (mornings and evenings) to affected areas over a 4-week period. They were instructed to include the face and other thin-skinned areas, if affected. Efficacy was assessed during scheduled visits at baseline (day 1), week 2, week 4 (or end of treatment), and 3 weeks after the end of treatment.

Patients and/or caregivers were instructed to assess pruritus for 24 hours prior to each study visit, using a pruritus score table. The investigators did not assess pruritus. Patients who were not able to read and/or understand the score table had their pruritus scored by investigator interview. Pruritus was scored 0–4, with a score of 0 meaning no itching and a score of 4 meaning severe/constant itching (disrupting sleep and activities).

In addition, patients or caregivers completed the Dermatology Life Quality Index (DLQI) or the Children's Dermatology Life Quality Index questionnaire at baseline and again at week 4.

Patients in the desonide group had significantly decreased mean pruritus at week 2 and week 4 compared with those in the vehicle group. Importantly, no rebound phenomenon was observed 3 weeks after the end of treatment for either group. The average pruritus scores at weeks 2 and 4 did not vary by age cohort.

The average quality of life measure was significantly improved for the patients on desonide compared with those on vehicle alone at week 4.

Dr. Friedlander disclosed that she has received grants for educational activities from Connetics and several other pharmaceutical companies.