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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06016361
Recruitment Status : Not yet recruiting
First Posted : August 29, 2023
Last Update Posted : August 29, 2023
Sponsor:
Information provided by (Responsible Party):
Entrinsic Bioscience Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Erythema Radiation Therapy, Secondary Skin Reactions Other: VS-200Cr Other: Standard of care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
Estimated Study Start Date : September 18, 2023
Estimated Primary Completion Date : March 18, 2024
Estimated Study Completion Date : March 18, 2024
Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Standard of Care
Standard of Care
 Other: Standard of care
AAD recommended course of care.
Active Comparator: Investigational Product
Investigational product
 Other: VS-200Cr
Topical cream with moisturizing factors.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Erythema [ Time Frame: Up to 12 weeks ]
    Evaluation of skin redness (both severity and size) with ScarletRed technology


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016361


Contacts
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Contact: Samantha Niles, MS 7818815165 sniles@entrinsic.com
Contact: Robert Kenefick, PhD 7818815165 rkenefick@entrinsic.com

Locations
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United States, Florida
Advocate Radiation Oncology
Fort Myers, Florida, United States, 33908
Contact: Samantha Niles, MS    781-881-5165    sniles@entrinsic.com   
Principal Investigator: Todd Pezzi, MD         
Sponsors and Collaborators
Entrinsic Bioscience Inc.
More Information
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Responsible Party: Entrinsic Bioscience Inc.
ClinicalTrials.gov Identifier: NCT06016361    
Other Study ID Numbers: PR-23809
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations