ClinicalTrials.gg
Not yet recruitingNCT06016361Updated Aug 29, 2023

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

An interventional study of VS-200Cr and Standard of care in Erythema and Radiation Therapy, Secondary Skin Reactions, sponsored by Entrinsic Bioscience Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by Entrinsic Bioscience Inc. · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Erythema
  • Radiation Therapy, Secondary Skin Reactions

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03

In context

Erythema

131 studies on the registry are indexed under Erythema; 17 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 114 interventional studies indexed under Erythema.

Browse Erythema studies →

Lead sponsor

Entrinsic Bioscience Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provision of signed and dated 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

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 Product or the Standard of Care.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Sham comparator
    Standard of Care

    Standard of Care

    Other: Standard of care

  • Active comparator
    Investigational Product

    Investigational product

    Other: VS-200Cr

Interventions

  • OtherVS-200Cr

    Topical cream with moisturizing factors.

  • OtherStandard of care

    AAD recommended course of care.

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What researchers measure

Primary outcomes

  1. Reduction in Erythema

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

    Time frame: Up to 12 weeks

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Study locations

1 site
  • Advocate Radiation Oncology
    Fort Myers, Florida 33908, United States
    • Samantha Niles, MS · Contactsniles@entrinsic.com · 781-881-5165
    • Todd Pezzi, MD · Principal investigator
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06016361
Lead sponsor
Entrinsic Bioscience Inc.
Responsible party
Sponsor
First posted
Aug 29, 2023
Start date
Sep 18, 2023 (estimated)
Primary completion
Mar 18, 2024 (estimated)
Completion
Mar 18, 2024 (estimated)
Last update
Aug 29, 2023

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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