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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06016361
Other study ID # PR-23809
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 18, 2023
Est. completion date March 18, 2024

Study information

Verified date August 2023
Source Entrinsic Bioscience Inc.
Contact Samantha Niles, MS
Phone 7818815165
Email sniles@entrinsic.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date March 18, 2024
Est. primary completion date March 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
VS-200Cr
Topical cream with moisturizing factors.
Standard of care
AAD recommended course of care.

Locations

Country Name City State
United States Advocate Radiation Oncology Fort Myers Florida

Sponsors (1)

Lead Sponsor Collaborator
Entrinsic Bioscience Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in Erythema Evaluation of skin redness (both severity and size) with ScarletRed technology Up to 12 weeks
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