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Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families.
IntroductionThe impact of crisaborole ointment, a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD), on quality of life (QoL) was assessed in two identically designed phase 3 studies (AD-301: NCT02118766; AD-302: NCT02118792, both at http://www.clinicaltrials.gov ).MethodsIn both studies, patients aged ≥ 2 years with mild to moderate AD per the Investigator's Static Global Assessment were randomly assigned 2:1 to receive crisaborole or vehicle twice daily for 28 days. QoL was assessed using the Children's Dermatology Life Quality Index (CDLQI) (2-15 years), the Dermatology Life Quality Index (DLQI) (≥ 16 years), and the Dermatitis Family Impact Questionnaire (DFI) (parents/caregivers/family of patients aged 2-17 years). Established QoL score severity bands provided clinical context.ResultsGreater mean improvement in QoL was observed in crisaborole-treated patients than in vehicle-treated patients at day 29 [mean change from baseline (∆BL), CDLQI: - 4.6 vs. - 3.0; P < 0.001; DLQI: - 5.2 vs. - 3.5; P = 0.015]. At baseline, more than half the patients had a "moderate effect" or higher of AD on QoL. At day 29, there was a trend toward more crisaborole- than vehicle-treated patients having "small effect" to "no effect", The QoL of parents/caregivers/family improved more for crisaborole-treated than for vehicle-treated patients (∆BL, DFI: - 3.7 vs. - 2.7; P = 0.003).ConclusionCrisaborole treatment results in clinically meaningful improvement in QoL for patients and their parents/caregivers/families.Trial registrationAD-301: http://www.clinicaltrials.gov , NCT02118766; AD-302: http://www.clinicaltrials.gov , NCT02118792.FundingAnacor Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., New York, NY
Management of infantile hemangiomas during the COVID pandemic
This article is made available for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.The COVID‐19 pandemic has caused significant shifts in patient care including a steep decline in ambulatory visits and a marked increase in the use of telemedicine. Infantile hemangiomas (IH) can require urgent evaluation and risk stratification to determine which infants need treatment and which can be managed with continued observation. For those requiring treatment, prompt initiation decreases morbidity and improves long‐term outcomes. The Hemangioma Investigator Group has created consensus recommendations for management of IH via telemedicine. FDA/EMA‐approved monitoring guidelines, clinical practice guidelines, and relevant, up‐to‐date publications regarding initiation and monitoring of beta‐blocker therapy were used to inform the recommendations. Clinical decision‐making guidelines about when telehealth is an appropriate alternative to in‐office visits, including medication initiation, dosage changes, and ongoing evaluation, are included. The importance of communication with caregivers in the context of telemedicine is discussed, and online resources for both hemangioma education and propranolol therapy are provided
Development of a Japanese Culturally Modified Version of the Childhood Atopic Dermatitis Impact Scale (JCMV-CADIS)
Background: The Childhood Atopic Dermatitis Impact Scale (CADIS) was developed to measure the impact of AD on QoL in both affected children and their families. However, no scale of this kind exists in Japan. The aims of this study were to validate the Japanese Culturally Modified Version of the CADIS (JCMV-CADIS) and to describe the family impact of children with AD in a Japanese context.
Methods: Participants included primary-caregivers for children with AD between 2 and 6 years of age. Interviews were conducted, and new items for the Japanese version were drafted. Reliability and validity were evaluated and compared with the original CADIS, and unique features of the Japanese version were analyzed.
Results: Exploratory factor analysis revealed the following factors: “Symptoms” and “Activity Limitations and Behavior” in the Child domain, and “Emotions Related to Social Factors,” “Emotions Related to the Child's Condition,” “Family and Social Function,” “Complexity of Care,” and “Approaches to Management of AD in Daily Life” in the Parent domain. The latter two factors were unique to the JCMV-CADIS and were not derived from the Original. “Emotion” was split into two independent factors. All factors showed good reliability (internal consistency and stability) and validity (concurrent validity and discriminant validity), except for the concurrent validity of “Approaches to Management of AD in Daily Life.” This factor seemed to reflect characteristics similar to the family-related function.
Conclusions: The JCMV-CADIS is a QoL scale developed for Japanese children with AD and their families. Further evaluation of clinical applicability is needed