Erythema, Radiation Therapy, Secondary Skin Reactions
Conditions
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 study is to assess if the investigational product can improve skin redness associated with radiation therapy. Participants will apply a moisturizer daily during the course of their prescribed radiation therapy for breast cancer. Researchers will compare against the standard of care.
Interventions
OTHERVS-200Cr
Topical cream with moisturizing factors.
OTHERStandard of care
AAD recommended course of care.
Sponsors
Entrinsic Bioscience Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Erythema | Up to 12 weeks | Evaluation of skin redness (both severity and size) with ScarletRed technology |
Countries
United States
Contacts
Primary ContactSamantha Niles, MS
Backup ContactRobert Kenefick, PhD
Outcome results
None listed