/ Active, not recruiting临床2期 A Randomised, Double-Blind, Vehicle-Controlled, Multi-Centre, Parallel-Group Study to Investigate the Safety, Tolerability, and Efficacy of GR1014 Cutaneous Gel as a Topical Radioprotector in the Prevention of the Radiodermatitis Occurring With Adjuvant Radiotherapy for Localised Breast Cancer After Lumpectomy
This clinical trial is testing a new skin gel called GR1014-CG to evaluate its safety and see if it can help prevent or reduce skin irritation (such as redness, soreness, etc.) caused by radiation therapy (RT) after breast-conserving surgery for early-stage breast cancer. The study is for women aged 18 and older who have had surgery to remove a breast tumor and need radiation therapy.
The main goals of the study are to find out:
* If GR1014-CG is safe to use
* If the gel can prevent or lower the severity of skin irritation caused by RT.
During the study participants will,
* Be randomly assigned to use one of two strengths of GR1014-CG (4.7% or 2.4%) or a placebo gel (a gel with no active drug).
* Apply the gel to the breast before each radiation session for 5 days.
* Visit the clinic once a week for 4 weeks to check their skin and overall health. At the end of the 4th week, if there are still signs of irritation participants will come to the clinic for a checkup 2 weeks after, and then again 2 weeks after if the irritation is still observed.
* Keep a diary to record any pain or itching they may feel.
100 项与 CVXL-0095 相关的专利(医药)