A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
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.
Epistemonikos ID: 36c95eb2f1e0b04e21b55a49369bb78d82bfaffe
First added on: Sep 26, 2025