Clinical Trials Logo
  1. Home
  2. Erythema
  3. NCT06016361
  4. Details
NCT06016361 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Withdrawn NCT04290273 - Characterisation of the Time-course Response of UV-induced Erythema N/A
Completed NCT01659853 - Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea Phase 3
Completed NCT00839462 - Efficacy of Dexpanthenol in Thermic Erythema Phase 2
Completed NCT03633877 - Durapore vs. Hy-Tape to Secure The Endotracheal Tube N/A
Active, not recruiting NCT02876107 - Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer Phase 2
Completed NCT06369675 - Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design Phase 1
Completed NCT03352323 - An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea Phase 3
Completed NCT06369727 - Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design Phase 1
Completed NCT03041064 - Multiday Beach Study N/A
Completed NCT02832141 - Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems
Completed NCT02131636 - Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea Phase 3
Terminated NCT01597921 - A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer N/A
Completed NCT01636765 - Study of Inter- and Intra-rater Reliability of the Clinician Erythema Assessment Scale
Completed NCT01124513 - Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI N/A
Terminated NCT03496584 - Effects of Phytonutrients on Vascular Health and Skin in Obese Males N/A
Completed NCT02737592 - A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects N/A
Completed NCT03852563 - A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering N/A
Completed NCT05300542 - Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema N/A
Completed NCT03477825 - Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin N/A
Completed NCT02490943 - A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS N/A