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

• Status: ACTIVE_NOT_RECRUITING
• Trial end date: 2026-10-30

Summary

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.

• Phase: PHASE2

Details

• Lead Sponsor: Graegis Pharmaceuticals Ltd
• Collaborator: Excelya
• Treatments: Radiotherapy