Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients

Johnson & Johnson (J&J)

Status

Completed

Conditions

Ichthyosis

Pruritus

Treatments

Other: Avena Sativa Skincare Regimen

Study type

Interventional

Funder types

Industry

Identifiers

NCT03796052

CCSSKA000844

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.