Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy

Launched by ENTRINSIC BIOSCIENCE INC. · Aug 23, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new moisturizing cream made with amino acids to see if it can help reduce skin redness caused by radiation therapy in breast cancer patients. If you are over 18 years old and have been diagnosed with breast cancer that requires radiation treatment, you might be eligible to participate. The study will ask participants to use the moisturizing cream daily while they undergo their radiation therapy, which is expected to last for about four weeks.

During the trial, researchers will compare how well this new cream works against the standard skincare routine typically recommended during radiation. It's important to note that if you have certain skin conditions, are pregnant or breastfeeding, or have allergies to the ingredients in the cream, you may not be able to join the study. This trial is not yet recruiting participants, so if you are interested, you will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provision of signed and dated informed consent form.
• • Aged over 18 years old.
• • Has been diagnosed with breast cancer and prescribed radiotherapy as a part of their cancer treatment.
• • Planned radiotherapy, as prescribed by the oncologist, is expected to provide a total radiation dose of up to 60 gray within the first 4 weeks of treatment.
• • Be able to adhere to proposed daily wound/site care as proposed by the protocol in line with the AADs recommendations.
• Exclusion Criteria:
• • Pre-existing skin conditions which in the opinion of the investigator could impact on the integrity of the study or compromise the safety of the patient (i.e., active eczema, psoriasis, or an open wound over the planned site of radiation).
• • Have a concurrent medical condition or poor functional baseline which in the opinion of the investigator would make them unsuitable or able to fully comply with the study protocol.
• • Are pregnant or actively breast feeding.
• • Known allergic reactions to ingredients of the Investigational Product or the Standard of Care.