Status:
UNKNOWN
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
Lead Sponsor:
Entrinsic Bioscience Inc.
Conditions:
Erythema
Radiation Therapy, Secondary Skin Reactions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical study is to evaluate a novel amino acid based moisturizing cream as part of the daily standard skincare regimen recommended during radiation therapy. The main aim of this stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 18 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06016361
Start Date
September 18 2023
End Date
March 18 2024
Last Update
August 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Advocate Radiation Oncology
Fort Myers, Florida, United States, 33908