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Omaveloxolone Lotion 0.5%

RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE

Ensayo de BIOGEN INC. en Cancer de mama.

Más ensayos de: Cáncer de mama.

Fase

Fase 2

Estado

Completado

Participantes

187

previstos

Centros

27

Fin del objetivo primario

abr 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en jun 2014.

Qué mide

Time-averaged Effect on Radiation Dermatitis Grade Measured With Common Terminology Criteria for Adverse Events (CTCAE, v 4.03) Following 3D Conformal Radiation Therapy to the Breast Following Topical Application of Omaveloxolone Lotion or Lotion Vehicle (Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroRadiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the resulting impact on overall quality of life, it can also be a dose-limiting toxicity requiring changes to the prescribed course of radiation therapy. The most common strategy employed in an attempt to prevent or minimize radiation dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the area clean, and minimizing exposure to potential mechanical irritants, such as scratching and rough clothing. However, this strategy has been shown to lack clinically significant efficacy. Consequently, there is a clinical need for new treatments that are effective in protecting against radiotherapy-induced oxidative stress and the subsequent development of radiation dermatitis. Based on data from previous studies in animals and humans, Reata believes that omaveloxolone (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology patients undergoing radiation therapy. This randomized, double-blind, vehicle-controlled, parallel-group trial will study the efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is recommended.

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Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02142959), actualizada en may 2025.