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

NCT06016361 | Unknown

• 1 other identifier: PR-23809
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythema; Radiation Therapy, Secondary Skin Reactions

Outcome Measures

Primary Outcomes (1)

• Reduction in Erythema

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

  Up to 12 weeks

Study Arms (2)

Standard of Care

SHAM COMPARATOR

Standard of Care

Other: Standard of care

Investigational Product

ACTIVE COMPARATOR

Investigational product

Other: VS-200Cr

Interventions

VS-200Cr OTHER

Topical cream with moisturizing factors.

Investigational Product

Standard of care OTHER

AAD recommended course of care.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Entrinsic Bioscience Inc.: lead

Study Sites (1)

Advocate Radiation Oncology

Fort Myers, Florida, 33908, United States

Location

MeSH Terms

Conditions

Erythema

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Samantha Niles, MS

CONTACT

7818815165; sniles@entrinsic.com

Robert Kenefick, PhD

CONTACT

7818815165; rkenefick@entrinsic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 29, 2023
• Study Start: September 18, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

US (1)