Calendario›PVLA›PTX-022
PTX-022
CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome
Ensayo de PALVELLA THERAPEUTICS, INC. en BCCs in Gorlin Syndrome Patients (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 73
- Centros
- 16
- Fin del objetivo primario
- mar 2023
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2021.
Qué mide
Number of new biopsy confirmed BCCs that develop on the face compared between the active and vehicle treatment arms (del registro, en inglés) (mes 6)
Cómo lo describe el promotor
En el documentoEn inglés, del registroA Phase 2b study looks at the safety and efficacy of a treatment that is being investigated for people with certain diseases. This study will be conducted at multiple centers in the United States where participants with Gorlin Syndrome, also known as basal cell nevus syndrome, will be randomly placed into two groups; one group will receive the active topical gel, the other a topical vehicle gel, also know as placebo. Participants will apply this topical product to their face once a day for 6 months. The study will be looking at the number of new BCCs that develop on the faces of all the participants during this time.
Más ensayos de PVLA
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| PTX-022 | Fase 3 | Reclutando pacientes | oct 2023 (prevista, ya pasada: sin actualizar en el registro) |
| TOIVA | Fase 2 | En marcha, sin reclutar | nov 2025 (real) |
| SELVA | Fase 3 | En marcha, sin reclutar | ene 2026 (real) |
| PTX-022 · LOTU | Fase 2 | Reclutando pacientes | ago 2027 (prevista) |
| VAPAUS | Fase 3 | Completado | jun 2023 (real) |
| PTX-022 | Fase 2 | Completado | nov 2022 (real) |
Todos los de PVLA, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04893486), actualizada en ago 2024.