Clinical trial NCT03796052: Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ichthyosis
Pruritus
Keywords: Pruritis
Itching
Dryness
Xerosis
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2019-01-08
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the same study regimen consisting of 3 products: a body wash, a body cream, and an anti-itch balm.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

  1. is currently undergoing therapy with a systemic agent and has completed at least 3 cycles without severe skin reactions.
  2. has received therapy with a systemic agent in the past 28 days.
  3. 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.

Primary outcomes:
measure: Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in CTCAE Grading of Pruritus
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Overall Xerosis Grading
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Overall Pruritus Grading
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Overall Irritation Assessment
timeFrame: Baseline to Week 5 +/- 1 week
Secondary outcomes:
measure: Frequency Distribution for Overall Tolerance at Visit 2 - Subject Rating
timeFrame: Week 5 +/- 1 week
measure: Frequency Distribution for Overall Tolerance at Visit 2 - Investigator Rating
timeFrame: Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Skindex-16 Global Score
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Skindex-16 Emotional Subscale
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Skindex-16 Symptoms Subscale
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Skindex-16 Functional Subscale
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Skin Moisture
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Skin Water Loss
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Self-Assessment of Dryness
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Self-Assessment of Flakiness
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Self-Assessment of Itchiness
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Self-Assessment of Roughness
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Self-Assessment of Smoothness
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Self-Assessment of Softness
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Self-Assessment of Comfort
timeFrame: Baseline to Week 5 +/- 1 week
measure: Mean Change from Baseline to Visit 2 in Self-Assessment of Overall Look/Feel
timeFrame: Baseline to Week 5 +/- 1 week
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mario Lacouture, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Common Terminology Criteria for Adverse Events (CTCAE). (2018, Mar 01). Retrieved from https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
citation: The PRO-CTCAE Measurement System. (2018, Sep 14). Retrieved from https://healthcaredelivery.cancer.gov/pro-ctcae/measurement.html
citation: Blume-Peytavi U, Kottner J, Sterry W, Hodin MW, Griffiths TW, Watson RE, Hay RJ, Griffiths CE. Age-Associated Skin Conditions and Diseases: Current Perspectives and Future Options. Gerontologist. 2016 Apr;56 Suppl 2:S230-42. doi: 10.1093/geront/gnw003.
citation: Skin Conditions. (2012, Jun 26). Retrieved from https://www.cancer.net/navigating-cancer-care/side-effects/skin-conditions