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

NCT07192588 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • Radiodermatitis; Acute

Interventions

DRUG

GR1014-CG 2.4%

Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL

DRUG

Vehicle Gel

The same topical formulation as GR1014-CG without the active ingredient amifostine thiol

RADIATION

Radiation Therapy

Ultra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast

DRUG

GR1014-CG 4.7%

Topical gel formulation of amifostine thiol (GR1014) at 50 mg/mL

Sponsors & Collaborators

  • Excelya

    collaborator INDUSTRY

  • Graegis Pharmaceuticals Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-26
Primary Completion
2026-09-30
Completion
2026-10-30

Countries

  • France
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07192588 on ClinicalTrials.gov