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

Primary Purpose

Erythema, Radiation Therapy, Secondary Skin Reactions

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VS-200Cr
Standard of care
Sponsored by
Entrinsic Bioscience Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Erythema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Advocate Radiation Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Standard of Care

Investigational Product

Arm Description

Standard of Care

Investigational product

Outcomes

Primary Outcome Measures

Reduction in Erythema
Evaluation of skin redness (both severity and size) with ScarletRed technology

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
August 23, 2023
Sponsor
Entrinsic Bioscience Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06016361
Brief Title
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
Official Title
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 18, 2023 (Anticipated)
Primary Completion Date
March 18, 2024 (Anticipated)
Study Completion Date
March 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entrinsic Bioscience Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Radiation Therapy, Secondary Skin Reactions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Sham Comparator
Arm Description
Standard of Care
Arm Title
Investigational Product
Arm Type
Active Comparator
Arm Description
Investigational product
Intervention Type
Other
Intervention Name(s)
VS-200Cr
Intervention Description
Topical cream with moisturizing factors.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
AAD recommended course of care.
Primary Outcome Measure Information:
Title
Reduction in Erythema
Description
Evaluation of skin redness (both severity and size) with ScarletRed technology
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Niles, MS
Phone
7818815165
Email
sniles@entrinsic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Kenefick, PhD
Phone
7818815165
Email
rkenefick@entrinsic.com
Facility Information:
Facility Name
Advocate Radiation Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Niles, MS
Phone
781-881-5165
Email
sniles@entrinsic.com
First Name & Middle Initial & Last Name & Degree
Todd Pezzi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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