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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-03-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Erythema Radiation Therapy, Secondary Skin Reactions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Standard of Care

Group Type SHAM_COMPARATOR

Standard of care

Intervention Type OTHER

AAD recommended course of care.

Investigational Product

Investigational product

Group Type ACTIVE_COMPARATOR

VS-200Cr

Intervention Type OTHER

Topical cream with moisturizing factors.

Interventions

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VS-200Cr

Topical cream with moisturizing factors.

Intervention Type OTHER

Standard of care

AAD recommended course of care.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No