ErythemaNCT06016361
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
A study testing VS-200Cr in people with Erythema and Radiation Therapy, Secondary Skin Reactions, run by Entrinsic Bioscience Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythema, Radiation Therapy, Secondary Skin Reactions
- What is being tested?
- VS-200Cr
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Radiation Oncology
Fort Myers, Florida, 33908
Samantha Niles, MS, 781-881-5165, sniles@entrinsic.com
Todd Pezzi, MD
About this study
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.
- Being tested
- VS-200Cr, Standard of care
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS-200CrOther
Topical cream with moisturizing factors.
Standard of careOther
AAD recommended course of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Sham comparator | Standard of Care Receives: Other: Standard of care |
| Investigational Product | Active comparator | Investigational product Receives: Other: VS-200Cr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Erythema
Evaluation of skin redness (both severity and size) with ScarletRed technology
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start18 Sep 2023 (estimated)
- Primary completion18 Mar 2024 (estimated)
- Study completion18 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entrinsic Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016361
- Sponsor's protocol ID
- PR-23809
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
- ClinicalTrials.gov ID
- NCT06016361
- Acronym / sponsor ID
- PR-23809
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Entrinsic Bioscience Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2023 (estimated)
- Primary completion
- 18 Mar 2024 (estimated)
- Study completion
- 18 Mar 2024 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Sham comparator | Other: Standard of careStandard of Care |
| Investigational Product | Active comparator | Other: VS-200CrInvestigational product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VS-200CrTopical cream with moisturizing factors. | Other | Investigational Product |
| Standard of careAAD recommended course of care. | Other | Standard of Care |
Primary outcome
Reduction in Erythema
Time frame: Up to 12 weeks
Evaluation of skin redness (both severity and size) with ScarletRed technology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VS-200Cr in people with Erythema and Radiation Therapy, Secondary Skin Reactions, run by Entrinsic Bioscience Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Niles, MS (7818815165, sniles@entrinsic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Erythema (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.