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

Not Applicable

Not yet recruiting

• Conditions: Erythema; Radiation Therapy, Secondary Skin Reactions
• Interventions: Other: VS-200Cr; Other: Standard of care

• Registration Number: NCT06016361
• Lead Sponsor: Entrinsic Bioscience Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-29
• Last Update Posted: 2023-08-29
• Study Start: 2023-09-18
• Primary Completion: 2024-03-18
• Study Completion: 2024-03-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Product	VS-200Cr	Investigational product
Standard of Care	Standard of care	Standard of Care

Primary Outcome Measures

Name	Time	Method
Reduction in Erythema	Up to 12 weeks	Evaluation of skin redness (both severity and size) with ScarletRed technology

Trial Locations

Locations (1)

Advocate Radiation Oncology; 🇺🇸 Fort Myers, Florida, United States