Status:
COMPLETED
Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
Lead Sponsor:
Johnson & Johnson Consumer Inc. (J&JCI)
Conditions:
Ichthyosis
Pruritus
Eligibility:
All Genders
18-75 years
Phase:
NA
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 w...
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 chem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2019
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03796052
Start Date
May 23 2019
End Date
December 18 2019
Last Update
November 4 2020
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10022