A Phase II Study of Oleogel-S10 Gel to Treat Skin Irritation from Radiation Therapy for Breast Cancer

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Full Title

A Randomized Phase II Study of The Efficacy of Oleogel-S10 (AP101) Gel for the Treatment of Grade 2/3 Radiation Dermatitis in Breast Cancer Patients

Purpose

Some people who receive radiation therapy for breast cancer develop skin irritation (“radiation dermatitis”). In this study, researchers are assessing the use of a gel called Oleogel-S10 to treat radiation dermatitis because this product has shortened the healing time for other types of skin wounds, such as burns. They want to see if Oleogel-S10 is effective when used in combination with a standard wound treatment cream called triamcinolone. Triamcinolone is often used to treat moderate to severe skin irritation such as that caused by poison ivy, eczema, sunburn, and rashes.

Participants in this study will be randomly assigned to receive triamcinolone cream with either Oleogel-S10 or a placebo (inactive) gel for 21 days.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have moderate to severe dermatitis that developed during days 20-25 of radiation treatment for breast cancer.
  • At least 4 weeks must pass between the completion of surgery or chemotherapy and the start of radiation therapy.
  • People with inflammatory breast cancer may not participate.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Alina Markova at 646-608-2342.

Protocol

21-091

Phase

II

Investigator