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

Erythema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06016361
• Other study ID #: PR-23809
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Erythema

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