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GVS assessment of crisaborole (Staquis) for the treatment of atopic dermatitis GVS assessment of crisaborole (Staquis®) for the treatment of atopic dermatitis | Report | National Health Care Institute Go to content You are here: Home Publications GVS assessment of crisaborole (Staquis®) for the treatment of atopic dermatitis Search within English part of National Health Care Institute Search GVS assessment of crisaborole (Staquis®) for the treatment of atopic dermatitisThe National Health Care Institute has completed its assessment whether crisaborole (Staquis®) is interchangeable with a product that is included in the medication reimbursement system (GVS). The National Health Care Institute recommends that crisaborole should not be included in the GVS.Download "GVS assessment of crisaborole
Efficacy and Safety of Proactive Therapy with 2% Crisaborole Ointment in Children with Mild-to-Moderate Atopic Dermatitis: A Randomized Controlled Study. The effectiveness of crisaborole for proactive treatment of atopic dermatitis (AD) is not well established. This study aims to investigate the efficacy and safety of a proactive treatment strategy with 2% crisaborole ointment for managing mild -to-moderate AD in children. In this 16-week randomized-controlled trial, children aged 2-17 years with mild-to-moderate AD were enrolled. All participants received treatment with 0.1% mometasone furoate cream for 2 weeks. Those with an IGA score of ≤ 1 were randomly assigned in a 1:1 ratio to either the proactive treatment group, which received crisaborole combined with emollient twice daily
Successful treatment of generalized inflammatory linear verrucous epidermal nevus with a somatic mutation in KRT10 with crisaborole 2% ointment. Inflammatory linear verrucous epidermal nevus (ILVEN) is a rare skin disorder characterized by pruritic, erythematous, hyperkeratotic papules and plaques following the lines of Blaschko. Pathogenesis of ILVEN is not yet clear and treatment remains challenging. We analyzed the molecular basis of generalized ILVEN in a Chinese girl and evaluated the therapeutic effect of topical crisaborole 2% ointment. The patient was found to carry a somatic heterozygous c.467G > A (p.Arg156His) mutation in the KRT10 gene. Expressions of IFN-γ, IL-12, IL-23 and IL-17A at mRNA level in her lesions were elevated. An excellent response was achieved after application
Real-world efficacy of 2% crisaborole ointment on chronic hyperplasia lesions in 49 patients with atopic dermatitis. Crisaborole, as a phosphodiesterase 4 (PDE4) inhibitor (PDE4i), effectively inhibits inflammatory pathways, showing promising results in atopic dermatitis (AD), particularly in chronic hyperplasia lesions. Based on real-world data from China, this study assesses the effectiveness
Efficacy and safety of crisaborole ointment, 2%, in participants aged ≥45 years with stasis dermatitis: Results from a fully decentralized, randomized, proof-of-concept phase 2a study. Crisaborole ointment, 2%, is a nonsteroidal topical phosphodiesterase 4 inhibitor approved for the treatment of mild-to-moderate atopic dermatitis. To evaluate the efficacy and safety of crisaborole in stasis dermatitis (SD). In this randomized, double-blind, vehicle-controlled, decentralized phase 2a study (NCT04091087), 65 participants aged ≥45 years with SD without active ulceration received crisaborole or vehicle (1:1) twice-daily for 6 weeks. The primary end point was percentage change from baseline in total sign score at week 6 based on in-person assessment. Crisaborole-treated participants had
Improved patient- and caregiver-reported outcomes distinguish tacrolimus 0.03% from crisaborole in children with atopic dermatitis. Atopic dermatitis (AD) is a chronic skin disease that affects 20% of children worldwide and is associated with low patient-reported quality of life (QoL). Crisaborole (CRIS) and tacrolimus 0.03% (TAC) are Food and Drug Administration (FDA)-approved topical treatments for mild to moderate AD with similar clinical efficacy. Utilization of patient-reported outcomes (PROs) may provide meaningful data on the impact of AD treatments on patients and caregivers. This study used PROs to monitor the impact of crisaborole (CRIS) and tacrolimus 0.03% (TAC) on children with mild/moderate atopic dermatitis (AD) and caregiver burden. This open-label study randomized 47
Maintenance of Investigator's Static Global Assessment Response with Once-Daily Crisaborole in Participants with Mild to Moderate Atopic Dermatitis. Treatments for atopic dermatitis (AD) often fail to achieve lasting disease control. In the CrisADe CONTROL phase III study (ClinicalTrials.gov: NCT04040192), participants aged ≥ 3 months with mild to moderate AD treated with once-daily (QD ) crisaborole, following initial treatment success with crisaborole twice daily (BID), had longer periods of flare-free maintenance, a higher number of flare-free days, and a lower number of flares compared with those who received vehicle. The study was an exploratory analysis of data on the maintenance of response per Investigator's Static Global Assessment (ISGA; ISGA score of 0 [clear] or 1 [almost clear
Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged ≥ 2 Years with Mild to Moderate Atopic Dermatitis. Atopic dermatitis (AD) is a chronic immuno-inflammatory skin disease. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor approved for the treatment of mild to moderate AD. This post hoc analysis assesses the efficacy and safety of crisaborole in Chinese patients aged ≥ 2 years with mild to moderate AD. We evaluated the efficacy and safety of crisaborole in Chinese patients from the vehicle-controlled, phase 3 CrisADe CLEAR study. Patients were randomly assigned 2:1 to receive crisaborole or vehicle twice daily, respectively, for 28 days. The primary endpoint was percent change from baseline in Eczema Area and Severity Index (EASI) total score
Impact of Crisaborole in Treatment-Experienced Patients With Mild-to-Moderate Atopic Dermatitis. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of patients with mild-to-moderate atopic dermatitis (AD). To assess the efficacy and safety of crisaborole in patients with AD who had received prior treatment with () corticosteroids (systemic or topical ) or topical calcineurin inhibitors (TCIs) or () topical corticosteroids (TCSs) or TCIs or () who were treatment-naive (TN). This post hoc analysis comprised patients aged ≥2 years with mild-to-moderate AD. Patients were assigned (2:1) to receive crisaborole or vehicle twice daily for 28 days. Patient response was assessed with the Investigator's Static Global Assessment (ISGA), Dermatology Life Quality
Comparative evaluation of the efficacy and safety of crisaborole ointment (2%) versus tacrolimus ointment (0.1%) for the topical treatment of atopic dermatitis: an open-labeled single-blinded randomized controlled trial.
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Clinical efficacy evaluation of crisaborole ointment in the treatment of vulvar leukoplakia. The aim of this study was to evaluate the clinical efficacy of crisaborole ointment in the treatment of vulvar leukoplakia. A prospective, randomized controlled clinical trial was conducted, and a total of 100 patients with vulvar leukoplakia were divided into the observation group (n=50) treated with crisaborole ointment and the control group (n=50) treated with vitamin E. The symptom improvement and vulvar leukoplakia score after 2 weeks of treatment were analyzed, and the clinical efficacy of vulvar leukoplakia was evaluated by referring to the Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine (2018 Edition). After 2 weeks of treatment, the overall score of lesions
Efficacy and safety of crisaborole ointment in Chinese and Japanese patients aged ≥2 years with mild-to-moderate atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin disease with a significant impact on the overall wellbeing of patients and their families. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor approved for the treatment of mild-to-moderate atopic dermatitis in multiple countries. However, in the key pivotal trials, a low proportion of the overall patient population was Asian, therefore the safety and efficacy of crisaborole in the Asian population with atopic dermatitis remains unclear. CrisADe CLEAR was a multicenter, randomized, double-blind, vehicle-controlled, phase 3 study (NCT04360187) to assess the efficacy and safety of crisaborole ointment
Crisaborole reverses dysregulation of the mild to moderate atopic dermatitis proteome towards nonlesional and normal skin. Safe and effective long-term topical treatments for atopic dermatitis (AD) remain limited. In this phase 2a, single-center, intrapatient, vehicle-controlled study, we examine the mechanism of action of crisaborole 2% ointment, a topical nonsteroidal PDE4 inhibitor , in a proteomic analysis of 40 adults with mild-to-moderate AD and 20 healthy subjects. Within the AD cohort, two target lesions were randomized in an intrapatient (1:1) manner to double-blind crisaborole/vehicle applied twice daily for 14 days. Punch biopsy specimens were collected for biomarker analysis at baseline from all participants, then from AD patients only at day 8 (optional) and day 15. Compared
Crisaborole efficacy in murine models of skin inflammation and Staphylococcus aureus infection. Phosphodiesterase 4 (PDE4) is highly expressed in keratinocytes and immune cells and promotes pro-inflammatory responses upon activation. The activity of PDE4 has been attributed to various inflammatory conditions, leading to the development and approval of PDE4 inhibitors as host-directed therapeutics in humans. For example, the topical PDE4 inhibitor, crisaborole, is approved for the treatment of mild-to-moderate atopic dermatitis and has shown efficacy in patients with psoriasis. However, the role of crisaborole in regulating the immunopathogenesis of inflammatory skin diseases and infection is not entirely known. Therefore, we evaluated the effects of crisaborole in multiple mouse models, including
Once-Daily Crisaborole Ointment, 2%, as a Long-Term Maintenance Treatment in Patients Aged ≥ 3 Months with Mild-to-Moderate Atopic Dermatitis: A 52-Week Clinical Study. Topical treatments for atopic dermatitis (AD) used reactively often fail to achieve lasting disease control; many of these therapies are associated with safety concerns that limit long-term use. Crisaborole ointment, 2 %, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD that has potential as a long-term maintenance therapy. The aim was to evaluate the long-term efficacy and safety of crisaborole once daily (QD) compared to vehicle QD as a maintenance therapy to reduce the incidence of flares in patients with AD who previously responded to crisaborole twice daily (BID). CrisADe CONTROL
Impact of Crisaborole on Sleep Outcomes in Pediatric Patients with Mild-to-Moderate Atopic Dermatitis. Using data from three clinical trials, the effect of crisaborole treatment on sleep outcomes for pediatric patients with atopic dermatitis (AD) and their families was examined. This analysis comprised patients aged 2 to < 16 years from the double-blind phase 3 CrisADe CORE 1 (NCT02118766 ) and CORE 2 (NCT02118792) studies, families of patients aged 2 to < 18 years from CORE 1 and CORE 2, and patients aged 3 months to < 2 years from the open-label phase 4 CrisADe CARE 1 study (NCT03356977), all with mild-to-moderate AD who received crisaborole ointment 2% twice daily for 28 days. Sleep outcomes were assessed via the Children's Dermatology Life Quality Index and Dermatitis Family Impact
Crisaborole Inhibits Itch and Pain by Preventing Neutrophil Infiltration in a Mouse Model of Atopic Dermatitis. Crisaborole, a phosphodiesterase 4 (PDE4) inhibitor, has been approved for the treatment of mild to moderate atopic dermatitis. Atopic dermatitis is often associated with increased pain. Using a mouse model, this study investigated whether crisaborole suppresses pain associated with atopic dermatitis and the potential mechanisms underlying it. The mouse model for atopic dermatitis was developed by repeatedly applying MC903. MC903-treated mice had increased spontaneous scratching (itch-related behaviour) and wiping behaviour (pain-related behaviour). Crisaborole was topically applied to the cheek skin of MC903-treated mice, and it reduced both itch- and pain-related behaviours