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

Entrinsic Bioscience

Status: Not yet enrolling

Conditions: Erythema; Radiation Therapy, Secondary Skin Reactions

Treatments: Other: VS-200Cr; Other: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT06016361

PR-23809

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Standard of Care

Sham Comparator group

Description:

Standard of Care

Treatment:

Other: Standard of care

Investigational Product

Active Comparator group

Description:

Investigational product

Treatment:

Other: VS-200Cr