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



Status:Not yet recruiting
Conditions:Allergy, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Otolaryngology
Healthy:No
Age Range:18 - 80
Updated:3/10/2019
Start Date:April 15, 2019
End Date:June 30, 2019
Contact:Judith Nebus
Email:jnebus@its.jnj.com
Phone:9088741302

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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

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.

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.

Inclusion Criteria:

- able to read, write, speak, and understand English

- has signed Photograph Release and Informed Consent

- 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:

- 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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-6014
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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mi
from
New York, NY
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