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- Ensayo de fase 3, aleatorizado, controlado con principio activo, de 2 grupos paralelos, con enmascaramiento para el evaluador y 24 semanas de duración, para comparar la eficacia y la seguridad de delgocitinib crema de 20 mg/g dos veces al día frente a alitretinoína, cápsulas una vez al día, en participantes adultos con eczema de manos crónico severo.
Ensayo de fase 3, aleatorizado, controlado con principio activo, de 2 grupos paralelos, con enmascaramiento para el evaluador y 24 semanas de duración, para comparar la eficacia y la seguridad de delgocitinib crema de 20 mg/g dos veces al día frente a alitretinoína, cápsulas una vez al día, en participantes adultos con eczema de manos crónico severo.
Dades bàsiques
- Protocol:
- LP0133-1528
- EURDRACT:
- 2021-003543-16
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2023
- Any de finalització:
- 2024
Objectius del projecte
Objetivo Principal: Comparar la eficacia y la calidad de vida relacionada con la salud de la aplicación tópica dos veces al día de delgocitinib en crema frente a la administración oral una vez al día de alitretinoína en cápsulas en el tratamiento de pacientes con CHE severo. Objetivos Secundarios: Comparar la seguridad de la aplicación tópica dos veces al día de delgocitinib en crema frente a la administración oral una vez al día de alitretinoína en cápsulas en el tratamiento de pacientes con CHE severo.
Documents
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Participants
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
"Phytophotodermatitis as a clinical problem and as a therapeutic option: case report and review of the literature".
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Article. 10.1016/j.pdpdt.2023.103304. 2023
[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
López DF; (...); Ortiz-Romero, P. L.
Article. 10.1016/j.ad.2022.11.013. 2023
[[Translated article]]Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.
Sanchez-Diaz, M; (...); Carrascosa-Carrillo, J M
Article. 10.1016/j.ad.2024.01.019. 2024
[Translated article] BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings.
Munera-Campos M; (...); Carrascosa JM
Article. 10.1016/j.ad.2023.05.010. 2023
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings.
Munera-Campos M; (...); Carrascosa JM
Article. 10.1016/j.ad.2023.03.001. 2023
Bladder cancer patients have increased NETosis and impaired DNaseI-mediated NET degradation that can be therapeutically restored in vitro.
Article. 10.3389/fimmu.2023.1171065. 2023
Casal necklace.
Mansilla-Polo, Miguel, Martin-Torregrosa, Daniel, Botella-Estrada, Rafael
Article. 10.1016/j.medcli.2023.03.035. 2023
Clinicopathological characteristics of cutaneous and mucocutaneous leishmaniasis in patients treated with TNF-alpha inhibitors.
Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael
Article. 10.1111/ddg.15007. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
Contact dermatitis by face mask.
Mansilla-Polo M, Navarro-Mira MÁ, Botella-Estrada R
Article. 10.1016/j.medcli.2023.01.004. 2023
Cutaneous larva migrans.
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Article. 10.1016/j.medcli.2023.03.037. 2023
Cutaneous sarcoidosis after platelet-rich plasma injections and permanent eyebrow make-up.
Torregrosa DM; (...); Estrada RB
Case Reports. 10.1016/j.ad.2023.06.023. 2024
Characterizing chronic hepatitis delta in Spain and the gaps in its management
Rodriguez-Tajes, Sergio; (...); Lens, Sabela
Meeting Abstract. 2023
Dermatologic consultations for patients hospitalized in non-dermatologic wards: results of a 384-patient cross-sectional study from a tertiary referral hospital.
Mansilla-Polo, M; (...); Botella-Estrada, R
Case Reports. 10.1016/j.ad.2023.11.021. 2023
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Development and validation of a model to predict complex Mohs Micrographic Surgery in clinical practice: REGESMOSH scale.
Montero-Vilchez, Trinidad R.; (...); Sanmartin-Jimenez, Onofre
Article. 10.1111/jdv.19056. 2023
Dose reduction is a feasible strategy in patients with plaque psoriasis who achieve sustained response with secukinumab: a retrospective, multicenter cohort study in daily practice setting
Daudén E; (...); Llamas-Velasco M
Article. 10.1111/ijd.16915. 2024
Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: a Spanish multicenter cohort study
Lasheras-Pérez MA; (...); Rodríguez-Serna M
Article. 10.1111/ijd.17030. 2024
Drug survival and safety of biosimilars and originator adalimumab in the treatment of psoriasis: a multinational cohort study.
Phan, Duc Binh; (...); Yiu ZZN
Article. 10.1136/bmjopen-2023-075197. 2023
Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP).
Rodriguez, C Couselo; (...); Florez, A.
Article. 10.1016/j.ad.2023.07.014. 2023
Dupilumab for atopic dermatitis during pregnancy and breastfeeding: Clinical experience in 13 patients.
Escolà H; (...); Curto-Barredo L
Letter. 10.1111/jdv.19165. 2023
Effectiveness and safety of brodalumab in the treatment of plaque, scalp and palmoplantar psoriasis: A multicentre retrospective study in a Spanish population.
Sahuquillo-Torralba, A; (...); Botella-Estrada, R
Article. 10.1111/ajd.14130. 2023
Effectiveness of Secukinumab for the treatment of erythrodermic psoriasis. Multicenter study in daily practice.
Reymundo, A; (...); Dauden, E
Letter. 10.1111/jdv.19371. 2023
Effectiveness, safety and satisfaction of 1% tirbanibulin ointment in the treatment of actinic keratoses: A prospective study in real clinical practice.
Mansilla-Polo M; (...); Botella-Estrada R
Letter. 10.1111/ajd.14151. 2023
Fatal outcome in classic Kaposi's sarcoma.
Mansilla-Polo M, Botella-Estrada R
Article. 10.1016/j.ad.2023.03.013. 2024
Four-year epidemiological surveillance of the Spanish Registry of Contact Dermatitis and Cutaneous Allergy (REIDAC): Current situation and trends.
Romero FT; (...); de Frutos JO
Article. 10.1016/j.ad.2023.10.039. 2024
Hemihypoatrophy as an extraordinary manifestation of linear morphoea.
Mansilla-Polo, Miguel, Navarro-Mira, Miguel A., Botella-Estrada, Rafael
Article. 10.1093/rap/rkac104. 2022
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Identification of c.104T>G, p.Met35Arg (NM_00314.8) variant in heterozygosity in exon 2 of the PTEN gene as the Causative Factor for Cowden Syndrome: A Medical Case Study.
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Article. 10.1093/ced/llad344. 2023
Innovations of Spanish code of medical deontology
Lasheras-Pérez MA; (...); Unamuno Bustos B
Letter. 10.1016/j.semerg.2023.102137. 2024
Klinisch-pathologische Eigenschaften kutaner und mukokutaner Leishmaniose bei mit TNF-a-Inhibitoren behandelten Patienten.
Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael
Article. 10.1111/ddg.15007_g. 2023
LC-MS metabolomics of urine reveals distinct profiles for non-muscle-invasive and muscle-invasive bladder cancer
Oto, Julia; (...); Medina, Pilar
Article. 10.1007/s00345-022-04136-7. 2022
Long-term follow-up of HCV-infected patients with end-stage chronic kidney disease after sustained virological response with direct-acting antiviral therapy
Martinez-Camprecios, Joan; (...); Buti, Maria
Article. 10.1016/j.gastrohep.2022.12.004. 2023
Melanoma and LEOPARD Syndrome: Understanding the Role of PTPN11 Mutations in Melanomagenesis.
Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael
Article. 10.2340/actadv.v104.14720. 2024
Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future.
Mansilla-Polo M, Escutia-Muñoz B, Botella-Estrada R
Article. 10.1016/j.ad.2023.08.001. 2023
Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future.
Mansilla-Polo, M., Escutia-Munoz, B., Botella-Estrada, R.
Article. 10.1016/j.ad.2023.05.015. 2023
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
Papulonecrotic tuberculides as a key to the diagnosis of tuberculosis: a case report.
Mansilla-Polo M; (...); Botella-Estrada R
Letter. 10.1111/ijd.16940. 2024
Patch Testing in Patients With Severe Atopic Dermatitis Treated With Dupilumab: A Multicentric Approach in Spain.
Docampo-Simon, Alexandre; (...); Silvestre, Juan F.
Article. 10.1089/derm.2022.0023. 2023
Pharmacogenetic biomarkers for secukinumab response in psoriasis patients in real-life clinical practice.
Munoz-Aceituno, E.; (...); de la Fuente, H.
Article. 10.1111/jdv.19782. 2023
Podoconiosis.
Mansilla-Polo, Miguel, Lopez-Leon, Paula Teresa, Botella-Estrada, Rafael
Article. 10.1001/jamadermatol.2023.4143. 2023
Porto sinusoidal vascular liver disorder: natural history and long-term outcome
Magaz, Marta; (...); Garcia Pagan, Juan Carlos
Meeting Abstract. 2023
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
Falkenhain-Lopez, D; (...); Ortiz-Romero, P L
Article. 10.1016/j.ad.2022.11.010. 2023
Prognostic factors for satellitosis or in-transit metastasis in cutaneous squamous cell carcinoma: A multicentric cohort study.
Marti-Marti I; (...); Toll A
Article. 10.1016/j.jaad.2023.02.048. 2023
Raccoon eyes as a diagnostic key for suspected amyloidosis
Mansilla-Polo, Miguel, Botella-Estrada, Rafael
Editorial Material. 10.1093/rap/rkad105. 2023
Reactive arthritis.
Mansilla-Polo M; (...); Botella-Estrada R
Article. 10.1016/j.medcli.2023.08.017. 2023
Real-life effectiveness of voxilaprevir/sofosbuvir/velpatasvir in hepatitis C patients previously treated with sofosbuvir/velpatasvir or glecaprevir/pibrentasvir
Ruiz-Cobo, Juan Carlos; (...); Lens, Sabela
Meeting Abstract. 2023
Recalcitrant Hailey-Hailey Disease With Satisfactory Response to Apremilast.
Mansilla-Polo, M; (...); Botella-Estrada, R
Case Reports. 10.1016/j.ad.2023.05.022. 2023
Refractory cutaneous lupus erythematosus successfully treated with anifrolumab: a case series.
Martin-Torregrosa, Daniel; (...); Torres-Navarro, Ignacio
Letter. 10.1111/ijd.17022. 2024
Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.
Sanchez-Diaz, M.; (...); Carrascosa-Carrillo, J. M.
Article. 10.1016/j.ad.2023.10.016. 2023
Rivaroxaban improves survival and decompensation in cirrhotic patients with moderate liver dysfunction. Double-blind, placebocontrolled trial
Puente Sanchez, Angela; (...); Garcia Pagan, Juan Carlos
Meeting Abstract. 2023
Rosai-Dorfman disease.
Lasheras-Pérez MA, Martín-Torregrosa D, Unamuno-Bustos B
Article. 10.1016/j.medcli.2023.09.029. 2024
Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry.
Lluch-Galcera, Juan Jose; (...); Garcia-Doval, Ignacio
Article. 10.1093/bjd/ljad382. 2023
Scalp Melanoma: A High-Risk Subset of Cutaneous Head and Neck Melanomas with Distinctive Clinicopathological Features.
Palacios-Diaz RD; (...); Botella-Estrada R
Article. 10.3390/jcm12247643. 2023
Sensitization to isothiazolinones in the Spanish Contact Dermatitis Registry (REIDAC): 2019-2021 epidemiological situation.
Hernandez Fernandez, Carlos Pelayo; (...); Garcia Doval, Ignacio
Article. 10.1111/cod.14251. 2022
Single Digital Metastasis of Rectal Adenocarcinoma
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Letter. 10.1097/DAD.0000000000002529. 2023
Skin lesions in a lung transplant recipient.
Mansilla-Polo M; (...); Botella-Estrada R
Case Reports. 10.1016/j.eimce.2023.09.005. 2024
Sodium metabisulfite a current low relevant allergen in Spain.
Sanz-Sanchez, Tatiana; (...); Borrego, Leopoldo
Letter. 10.1111/jdv.19702. 2023
Successful treatment of field of cancerization in the dorsum of the hands with 1% tirbanibulin ointment.
Abril-Perez, Carlos; (...); Botella-Estrada, Rafael
Article. 10.1093/ced/llad171. 2023
Survey to evaluate the implementation of the recommendations on the comprehensive diagnosis of viral hepatitis in a single extraction: where are we?
Cabezas, Joaquin; (...); Crespo, Javier
Meeting Abstract. 2023
SURVEY TO EVALUATE THE IMPLEMENTATION OF THE RECOMMENDATIONS ON THE COMPREHENSIVE DIAGNOSIS OF VIRAL HEPATITIS IN A SINGLE EXTRACTION: WHERE ARE WE?
Cabezas, Joaquin; (...); Crespo Garcia, Javier
Meeting Abstract. 2023
Switching from dupilumab to tralokinumab in patients with atopic dermatitis due to inefficacy or side effects.
Lasheras-Pérez MA; (...); Rodriguez-Serna M
Article. 10.1111/ijd.16926. 2024
Tattoo-Associated Common Wart.
Mansilla-Polo, M, Llavador-Ros, M, Botella-Estrada, R
Article. 10.1016/j.ad.2023.04.037. 2023
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023