A NON-INTERVENTIONAL, MULTI-NATIONAL, MULTI-CENTER POST-AUTHORIZATION SAFETY STUDY (PASS) TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF ODOMZO® (SONIDEGIB) ADMINISTERED IN PATIENTS WITH LOCALLY ADVANCED BASAL CELL CARCINOMA (LABCC): NISSO.
Datos básicos
- Protocolo:
- SPI-SON-2020-01
- EUDRACT:
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2021
- Año de finalización:
Documentos
- No hay documentos
Participantes
Financiadores - Promotores
Resultados del Ensayo Clínico
"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]]Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP).
Couselo-Rodríguez C; (...); Flórez Á
Article. 10.1016/j.ad.2023.07.028. 2024
[[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] Fatal outcome in classic Kaposi's sarcoma.
Mansilla-Polo M, Botella-Estrada R
Article. 10.1016/j.ad.2024.03.015. 2024
[Translated article] Moderate to Severe Psoriasis in Pediatric and Young Patients: The BIOBADADERM Registry Experience.
Nieto Benito, L M; (...); Garcia-Doval, I
Article. 10.1016/j.ad.2021.05.027. 2022
[Translated article] Risk of a Second Skin Cancer in a Cohort of Patients With Nonmelanoma Skin Cancer - Basal Cell Carcinoma or Squamous Cell Carcinoma - Treated With Mohs Micrographic Surgery: A National Prospective Cohort Study.
Minano Medrano, R.; (...); Garcia-Doval, I
Article. 10.1016/j.ad.2022.01.035. 2022
A Case of Localised Immediate Hypersensitivity Reaction to Bimekizumab.
Lasheras-Perez, Miguel Antonio; (...); Ibanez-Echevarria, Ethel
Article. 10.1111/cod.14774. 2025
Anti-Mi-2 Dermatomyositis with ulcerative plaques.
Palacios-Diaz RD; (...); Botella-Estrada, Rafael
Article. 10.1093/rheumatology/keac180. 2022
Association between Primary Cutaneous B-cell Lymphomas and Other Skin Cancers: A Multicentre Cohort Study
Avallone, Gianluca; (...); Quaglino, Pietro
Article. 10.2340/actadv.v102.319. 2022
BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings.
Munera-Campos M; (...); Carrascosa JM
Article. 10.1016/j.ad.2023.03.001. 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
Complications Associated with Mohs Micrographic Surgery: Data from the Nationwide Prospective Cohort REGESMOHS
Ruiz-Salas, Veronica; (...); Garcia-Doval, Ignacio
Article. 10.1159/000517010. 2021
Consensus-Based Recommendations on the Prevention of Squamous Cell Carcinoma in Solid Organ Transplant Recipients A Delphi Consensus Statement
Massey, Paul R.; (...); Jambusaria-Pahlajani, Anokhi
Article. 10.1001/jamadermatol.2021.3180. 2021
Contact dermatitis by face mask.
Mansilla-Polo M, Navarro-Mira MÁ, Botella-Estrada R
Article. 10.1016/j.medcli.2023.01.004. 2023
Correction: 'Lesion on the back of the hand in a hematopoietic stem cell transplant recipient'.
Mansilla-Polo M; (...); Botella-Estrada R
Correction. 10.1007/s15010-024-02259-0. 2024
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
Chikungunya fever with a positive tourniquet test: a novel description.
Mansilla-Polo M; (...); Botella-Estrada R
Article. 10.1093/ced/llae089. 2024
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.
Letter. 10.1016/j.ad.2024.10.030. 2024
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
Dermatological toxicities of talquetamab, a new bispecific antibody: case series and literature review.
Mansilla-Polo M; (...); Botella-Estrada R
Letter. 10.1111/ddg.15502. 2024
Dermatological toxicities of talquetamab, a new bispecificantibody: case series and literature review
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Letter. 10.1111/ddg.15502_g. 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
DNA Copy Number Variation Associated with Anti-tumour Necrosis Factor Drug Response and Paradoxical Psoriasiform Reactions in Patients with Moderate-to-severe Psoriasis
Sanz-Garcia, A; (...); Ovejero-Benito, MC
Article. 10.2340/00015555-3794. 2021
Does hyaluronidase injected in periocular area change skin ultrastructure?: Standardized in vitro analysis
Aguilar-González M; (...); Pérez-López M
Article. 10.1111/jocd.15014. 2022
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 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
Effect of Sex in Systemic Psoriasis Therapy: Differences in Prescription, Effectiveness and Safety in the BIOBADADERM Prospective Cohort
Hernandez-Fernandez, CP; (...); Garcia-Doval, I
Article. 10.2340/00015555-3711. 2021
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, 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
Erythema Elevatum Diutinum.
Mansilla-Polo M, Botella-Estrada R
Article. 10.1016/j.ad.2023.10.042. 2024
Fatal outcome in classic Kaposi's sarcoma.
Mansilla-Polo M, Botella-Estrada R
Article. 10.1016/j.ad.2023.03.013. 2024
Folliculotropic Mycosis Fungoides With Flexural Eruptive Cysts and Comedones in a 14-Year-Old Boy.
Roca-Gines, J; (...); Botella-Estrada, R
Article. 10.1097/DAD.0000000000001958. 2021
Guselkumab, Risankizumab, and Tildrakizumab demonstrate parallel effectiveness and safety in psoriasis treatment: a head-to-head comparative study in real clinical practice.
Mansilla-Polo M; (...); Botella-Estrada R
Article. 10.1016/j.abd.2024.04.004. 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
Herpes vegetans of the vulva.
Abril-Pérez C; (...); Botella-Estrada R
Article. 10.1016/j.ajog.2021.05.024. 2021
Histological deep margins in cutaneous squamous cell carcinoma of the scalp and risk of recurrence.
Verdaguer-Faja, Julia; (...); Jaka, Ane
Article. 10.1111/jdv.20250. 2024
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
Incomplete Mohs surgery: a long-term, nationwide prospective cohort to describe recurrence rate and risk factors (REGESMOHS, Spanish Registry of Mohs Surgery).
Oro-Ayude, M.; (...); REGESMOHS (Registro Español de Cirugía de Mohs)
Letter. 10.1111/jdv.17597. 2022
Interim analysis of the multinational, post-authorization safety study (NISSO) to assess the long-term safety of sonidegib in patients with locally advanced basal cell carcinoma
Gutzmer, Ralf; (...); Hauschild, Axel
Article. 10.1186/s12885-024-13101-z. 2024
Interparietal nodule in a 49-year-old woman.
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Case Reports. 10.1111/ddg.15398. 2024
Interparietaler Knoten bei einer 49-jährigen Frau
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Article. 10.1111/ddg.15398_g. 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
'Lesion on the back of the hand in a hematopoietic stem cell transplant recipient'.
Mansilla-Polo M; (...); Botella-Estrada R
Article. 10.1007/s15010-024-02214-z. 2024
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
MiR-138-5p Suppresses Cell Growth and Migration in Melanoma by Targeting Telomerase Reverse Transcriptase.
Tarazon, Estefania; (...); Botella Estrada, Rafael
Article. 10.3390/genes12121931. 2021
Moderate to Severe Psoriasis in Pediatric and Young Patients: The BIOBADADERM Registry Experience.
Nieto Benito LM; (...); García-Doval I
Case Reports. 10.1016/j.ad.2021.05.017. 2022
Mohs micrographic surgery in dermatofibrosarcoma protuberans: Rate and risk factors for recurrence in a prospective cohort study from the Spanish Registry of Mohs Surgery (REGESMOHS) and review of the literature.
Nieto-Benito LM; (...); Garcia-Doval I
Review. 10.1111/exd.14291. 2021
Mohs micrographic surgery in immunosuppressed vs immunocompetent patients: Results of a prospective nationwide cohort study (REGESMOHS, Spanish registry of Mohs surgery).
Abril-Pérez C; (...); Botella-Estrada R
Article. 10.1111/jdv.20103. 2024
Multiple pilomatricomas in a child with xeroderma pigmentosum: Coincidence or association?
Palacios-Diaz RD; (...); Botella-Estrada R
Article. 10.1111/pde.14924. 2022
Multiple Primary Melanomas: Retrospective Review in a Tertiary Care Hospital
Palacios-Diaz RD; (...); Botella-Estrada R
Article. 10.3390/jcm11092355. 2022
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
Nodular hidradenoma: Case report and brief literature review.
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Article. 10.1016/j.patol.2025.100801. 2025
Oral Ruxolitinib could Increase the Aggressiveness of Cutaneous Squamous Cell Carcinomas: A 6-Patient Series
Lasheras-Perez, M. A.; (...); Botella-Estrada, R.
Letter. 10.1016/j.ad.2023.07.035. 2025
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
Patients with primary cutaneous lymphoma are at risk for severe COVID-19. Data from the Spanish Primary Cutaneous Lymphoma Registry.
Sánchez-Velázquez A; (...); Ortiz-Romero PL
Letter. 10.1111/jdv.17430. 2021
Podoconiosis.
Mansilla-Polo, Miguel, Lopez-Leon, Paula Teresa, Botella-Estrada, Rafael
Article. 10.1001/jamadermatol.2023.4143. 2023
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
Primary cutaneous lymphomas in children: A prospective study from the Spanish Academy of Dermatology and Venereology (AEDV) Primary Cutaneous Lymphoma Registry.
Torre-Castro J; (...); Machan S
Article. 10.1111/pde.14811. 2021
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
Psoriasis onset over a fresh tattoo.
Abril-Perez, Carlos; (...); Botella-Estrada, Rafael
Article. 10.1016/j.medcli.2022.01.014. 2022
Raccoon eyes as a diagnostic key for suspected amyloidosis
Mansilla-Polo, Miguel, Botella-Estrada, Rafael
Editorial Material. 10.1093/rap/rkad105. 2023
Rationale and study design for an Individualized PeriopeRative Open lung VEntilatory approach in Emergency Abdominal Laparotomy/scopy: study protocol for a prospective international randomized controlled trial.
Laguna G; (...); Ferrando C
Article. 10.1016/j.redare.2024.04.007. 2024
Reactive arthritis.
Mansilla-Polo M; (...); Botella-Estrada R
Article. 10.1016/j.medcli.2023.08.017. 2023
Real-world effectiveness and safety of bimekizumab for hidradenitis suppurativa: An ambispective observational study.
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Article. 10.1111/ajd.14339. 2024
Recalcitrant Hailey-Hailey Disease With Satisfactory Response to Apremilast
Mansilla-Polo, M.; (...); Botella-Estrada, R.
Letter. 10.1016/j.ad.2024.10.025. 2024
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
Recalcitrant lichen planopilaris treated with upadacitinib: a case series
Lasheras-Perez, Miguel A.; (...); Botella-Estrada, Rafael
Article. 10.1111/ijd.17339. 2024
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
Risk Factors and Rate of Recurrence after Mohs Surgery in Basal Cell and Squamous Cell Carcinomas: A Nationwide Prospective Cohort (REGESMOHS, Spanish Registry of Mohs Surgery)
Tomas-Velazquez, Alejandra; (...); Redondo, Pedro
Article. 10.2340/actadv.v101.544. 2021
Risk of a Second Skin Cancer in a Cohort of Patients With Nonmelanoma Skin Cancer -Basal Cell Carcinoma or Squamous Cell Carcinoma-Treated With Mohs Micrographic Surgery: A National Prospective Cohort Study.
Miñano Medrano R; (...); García-Doval I
Article. 10.1016/j.ad.2022.01.003. 2022
Ruxolitinib for foreign body reaction to silicone in a patient with chronic graft-versus-host disease.
Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael
Letter. 10.1111/ijd.17365. 2024
Ruxolitinib oral puede aumentar la agresividad de los carcinomas escamosos cutáneos: serie de 6 pacientes.
Lasheras-Perez MA; (...); Botella-Estrada R
Article. 10.1016/j.ad.2024.10.003. 2025
Sarcoidosis cutánea tras inyecciones de plasma rico en plaquetas y maquillaje permanente de cejas.
Martín-Torregrosa D; (...); Botella-Estrada R
Article. 10.1016/j.ad.2024.10.043. 2024
Scaling and periorificial crusts in a pediatric patient.
Fayos-Gregori, Rafael; (...); Botella-Estrada, Rafael
Article. 10.1007/s15010-024-02309-7. 2024
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
Sentinel Lymph Node Biopsy vs. Observation in Thin Melanoma: A Multicenter Propensity Score Matching Study.
Tejera-Vaquerizo, Antonio; (...); Nagore, Eduardo
Article. 10.3390/jcm10245878. 2021
SfM-3DULC: Reliability of a new 3D wound measurement procedure and its accuracy in projected area.
Sánchez-Jiménez D; (...); Botella-Estrada R
Article. 10.1111/iwj.13595. 2021
Single Digital Metastasis of Rectal Adenocarcinoma
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Letter. 10.1097/DAD.0000000000002529. 2023
Skin cancer risk after hematopoietic stem cell transplantation: a systematic review and meta-analysis.
Mansilla-Polo M; (...); Botella-Estrada R
Article. 10.1111/ijd.17371. 2024
Skin lesions in a lung transplant recipient
Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael
Editorial Material. 10.1016/j.eimc.2023.09.005. 2024
Skin lesions in a lung transplant recipient.
Mansilla-Polo M; (...); Botella-Estrada R
Case Reports. 10.1016/j.eimce.2023.09.005. 2024
Study of Microsatellite Instability by Immunohistochemistry in a Cohort of Patients With Melanoma
Diaz, Rodolfo David Palacios; (...); Estrada, Rafael Botella
Article. 10.1111/cup.14758. 2025
Successful treatment of erythema nodosum leprosum with apremilast.
Abril-Perez, Carlos; (...); Botella-Estrada, Rafael
Letter. 10.1111/dth.15258. 2022
Successful treatment of erythema nodosum leprosum with upadacitinib and roflumilast.
Mansilla-Polo, Miguel; (...); Torres-Navarro, Ignacio
Letter. 10.1111/ijd.17293. 2024
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
Successful Treatment of Mogamulizumab-Associated Rash With Upadacitinib: Evidence From 2 Cases.
Martin-Torregrosa, Daniel; (...); Botella-Estrada, Rafael
Article. 10.1001/jamadermatol.2024.4582. 2024
Successful Treatment of Stimulator of Interferon Genes-Associated Vasculopathy of Infantile Onset SAVI Syndrome With Anifrolumab.
Mansilla-Polo M; (...); Botella-Estrada R
Article. 10.1001/jamadermatol.2024.2160. 2024
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
Symmetrical pustulosis unfolds over systemic lupus.
Abril-Perez, Carlos; (...); Botella-Estrada, Rafael
Article. 10.1093/rheumatology/keab529. 2021
Tattoo-Associated Common Wart
Mansilla-Polo, M., Llavador-Ros, M., Botella-Estrada, R.
Editorial Material. 10.1016/j.ad.2024.05.001. 2024
Tattoo-Associated Common Wart.
Mansilla-Polo, M, Llavador-Ros, M, Botella-Estrada, R
Article. 10.1016/j.ad.2023.04.037. 2023
The risk of hepatic adverse events of systemic medications for psoriasis: a prospective cohort study using the BIOBADADERM registry.
Munera-Campos, M; (...); Garcia-Doval, I
Article. 10.1080/09546634.2021.1922572. 2021
Treatment of palmoplantar psoriasis with oral roflumilast: a case series.
Lasheras-Perez, Miguel Antonio; (...); Botella-Estrada, Rafael
Article. 10.1093/ced/llae229. 2024
Use of an electrospun bioveil is safe and does not decrease skin graft take on burn wounds: A randomised, controlled clinical trial.
Perez-Del-Caz, Maria Dolores; (...); Perez-Plaza, Aranzazu
Article. 10.1016/j.burns.2025.107427. 2025
Vulvar and areolar fixed drug eruption.
Abril-Pérez C; (...); Botella-Estrada R
Article. 10.1016/j.ajog.2021.09.042. 2021
Zoon's vulvitis in association with severe vulvodynia.
Abril-Perez, Carlos; (...); Botella-Estrada R
Article. 10.1016/j.ajog.2022.01.033. 2022