A Single Center, Clinical Study to Determine the Safety and Efficacy of an Avena Sativa Skincare Regimen for Therapy-Related Pruritus and Xerosis in Cancer Patients
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Mean Change from Baseline to Visit 2 in Overall Pruritus Grading
Overview
Brief Summary
This study will test the safety and efficacy of three topical agents containing oat kernel flour to determine how well they relieve skin dryness and itching related to cancer therapies. Participants will receive a body wash, a body cream, and an anti-itch balm to use at home for 4-6 weeks.
Detailed Description
Many patients undergoing cancer therapies experience skin reactions like dry skin, rash, redness, itchiness, and hyperpigmentation. Dry skin and itching are especially common for those undergoing chemotherapy and targeted treatments.
Skincare products containing Avena sativa (oat) kernel flour have a long history of tolerance and efficacy in treating various skin conditions involving pruritus (itching) and xerosis (dry skin), as Avena sativa (oat) kernel flour is known for its skin protectant properties and soothing effects on skin. This study will evaluate the safety and efficacy of a regimen of three topical agents containing Avena sativa (oat) kernel flour for cancer patients experiencing mild to moderate pruritus and/or xerosis.
Participants will received the products at Baseline (Visit 1) and return to the clinical site at Week 5 +/- 1 week for Visit 2. In addition, questionnaires will be completed remotely between Baseline and Visit 2.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •able to read, write, speak, and understand English
- •has signed Informed Consent including Photograph Release
- •has a prior diagnosis of a solid or hematologic tumor and either:
- •is currently undergoing therapy with a systemic agent and has completed at least 3 cycles without severe skin reactions.
- •has received therapy with a systemic agent in the past 28 days.
- •is greater than 1 year status post allogeneic hematopoietic stem cell transplantation.
- •is undergoing one or more types of cancer treatment that are commonly known to cause mild to moderate skin reactions such as rash, dryness, and/or itching
- •is diagnosed with mild to moderate skin dryness (xerosis) and/or itching (pruritus).
- •is capable of all self-care and is up and mobile at least 50% of the day
- •intends to complete the study and is willing/able to follow all study instructions.
Exclusion Criteria
- •has known allergies or sensitivity to skincare products or study product ingredients.
- •has other skin conditions or diseases that the investigator thinks would interfere with the study or put the subject at higher risk (e.g. immunosuppressive diseases, skin infections, etc.)
- •has severe skin dryness, itching, or rash.
- •is undergoing radiation therapy.
- •is undergoing chemotherapy or adjuntive therapies known to commonly cause complex or severe skin reactions.
- •has uncontrolled diabetes.
- •is pregnant or planning to become pregnant during the study.
- •is participating in another study for which the participant is receiving a treatment or therapy (observational studies are okay).
- •is an employee or family member of the investigator, study site, or Sponsor.
Outcomes
Primary Outcomes
Mean Change from Baseline to Visit 2 in Overall Pruritus Grading
Time Frame: Baseline to Week 5 +/- 1 week
The investigator will question subjects for overall pruritus (skin itching) using a 0 (none) to 3 (severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Overall Irritation Assessment
Time Frame: Baseline to Week 5 +/- 1 week
The investigator will evaluate subjects for overall irritation using a 0 (none) to 4 (very severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis
Time Frame: Baseline to Week 5 +/- 1 week
The investigator will evaluate subjects for overall xerosis (skin dryness) using the Common Terminology Criteria for Adverse Events (CTCAE) grading scale. For xerosis, the scale ranges from 1 (dryness covering less 10% of body surface area and no associated erythema or pruritus) to 3 (dryness covering greater than 30% of body surface area and associated with itching; limits daily self care activities of daily living). A "0" grade will be used to document subjects with no presence of the CTCAE skin adverse event symptoms for xerosis. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in CTCAE Grading of Pruritus
Time Frame: Baseline to Week 5 +/- 1 week
The investigator will evaluate subjects for overall pruritus (skin itching) using the Common Terminology Criteria for Adverse Events (CTCAE) grading scale. For pruritus, the scale ranges from 1 (Mild or localized; topical intervention indicated) to 3 (widespread and constant itching; limits daily self-care activities or sleep). A "0" grade will be used to document subjects with no presence of the CTCAE skin adverse event symptoms for pruritus. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Overall Xerosis Grading
Time Frame: Baseline to Week 5 +/- 1 week
The investigator will evaluate subjects for overall xerosis (skin dryness) using a 0 (none) to 3 (severe) scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Secondary Outcomes
- Frequency Distribution for Overall Tolerance at Visit 2 - Subject Rating(Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Skindex-16 Emotional Subscale(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Skin Water Loss(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Skindex-16 Global Score(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Skin Moisture(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Self-Assessment of Softness(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Skindex-16 Symptoms Subscale(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Self-Assessment of Overall Look/Feel(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Skindex-16 Functional Subscale(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Self-Assessment of Flakiness(Baseline to Week 5 +/- 1 week)
- Frequency Distribution for Overall Tolerance at Visit 2 - Investigator Rating(Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Self-Assessment of Smoothness(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Self-Assessment of Dryness(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Self-Assessment of Itchiness(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Self-Assessment of Roughness(Baseline to Week 5 +/- 1 week)
- Mean Change from Baseline to Visit 2 in Self-Assessment of Comfort(Baseline to Week 5 +/- 1 week)