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

Primary Purpose

Ichthyosis, Pruritus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avena Sativa Skincare Regimen
Sponsored by
Johnson & Johnson Consumer Inc. (J&JCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ichthyosis focused on measuring Pruritis, Itching, Dryness, Xerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avena Sativa Skincare Regimen

Arm Description

Avena sativa-containing body wash, body cream, and anti-itch balm

Outcomes

Primary Outcome Measures

Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis
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
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
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).
Mean Change from Baseline to Visit 2 in Overall Pruritus Grading
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
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).

Secondary Outcome Measures

Frequency Distribution for Overall Tolerance at Visit 2 - Subject Rating
The subject will rate how well he/she tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated.
Frequency Distribution for Overall Tolerance at Visit 2 - Investigator Rating
The investigator will rate how well the participant tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated.
Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be completed for Skin Dryness. The question asks subjects to rate the severity of their dry skin at its worst over the last 7 days from None to Very Severe on a 5-point scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be completed for Itching. The question asks subjects to rate the severity of their itchy skin at its worst over the last 7 days from None to Very Severe on a 5-point scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Skindex-16 Global Score
The Skindex-16 is a dermatology-specific quality of life measuring tool. (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days they have been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The global score is the average score for all questions and is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Skindex-16 Emotional Subscale
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Emotional subscale looks at the average score of questions 5-11 regarding emotion; the emotional score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Skindex-16 Symptoms Subscale
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Symptoms subscale looks at the average score of questions 1-4 individual responses regarding symptoms; the symptoms score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Skindex-16 Functional Subscale
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Functional subscale looks at the average score of questions 12 - 16 regarding daily functioning; the functional score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Skin Moisture
Skin moisture will be measured with a Corneometer, with values ranging from 0 (no moisture) to 120 (most moisturized) arbitrary units. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Skin Water Loss
The amount of water lost through the skin will be measured with a Vapometer. Higher numbers indicate more water loss. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Self-Assessment of Dryness
Subjects will be asked to rate their overall skin dryness on a scale of 1 (very dry) to 10 (skin feels moisturized). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Self-Assessment of Flakiness
Subjects will be asked to rate their overall skin flakiness on a scale of 1 (flaking very apparent) to 10 (no visible flaking). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Self-Assessment of Itchiness
Subjects will be asked to rate their overall skin itchiness on a scale of 1 (very itchy) to 10 (not at all itchy). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 weeks).
Mean Change from Baseline to Visit 2 in Self-Assessment of Roughness
Subjects will be asked to rate their overall skin roughness/texture on a scale of 1 (very rough) to 10 (not at all rough). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 weeks).
Mean Change from Baseline to Visit 2 in Self-Assessment of Smoothness
Subjects will be asked to rate their overall skin smoothness on a scale of 1 (not at all smooth) to 10 (very smooth). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Self-Assessment of Softness
Subjects will be asked to rate their overall skin softness on a scale of 1 (not at all soft) to 10 (very soft). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Self-Assessment of Comfort
Subjects will be asked to rate their overall skin comfort on a scale of 1 (uncomfortable/irritated) to 10 (very comfortable/not at all irritated). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Mean Change from Baseline to Visit 2 in Self-Assessment of Overall Look/Feel
Subjects will be asked to rate the overall look and feel of their skin on a scale of 1 (not healthy looking) to 10 (healthy looking). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).

Full Information

First Posted
January 4, 2019
Last Updated
November 2, 2020
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03796052
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ichthyosis, Pruritus
Keywords
Pruritis, Itching, Dryness, Xerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avena Sativa Skincare Regimen
Arm Type
Experimental
Arm Description
Avena sativa-containing body wash, body cream, and anti-itch balm
Intervention Type
Other
Intervention Name(s)
Avena Sativa Skincare Regimen
Intervention Description
Regimen consisting of 3 topical agents containing Avena Sativa (oat) kernel flour: a body wash (type = cosmetic), a body cream (type = cosmetic), and an anti-itch balm (type = OTC monograph drug with 0.5% Pramoxine HCl)
Primary Outcome Measure Information:
Title
Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis
Description
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).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in CTCAE Grading of Pruritus
Description
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).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Overall Xerosis Grading
Description
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).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Overall Pruritus Grading
Description
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).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Overall Irritation Assessment
Description
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).
Time Frame
Baseline to Week 5 +/- 1 week
Secondary Outcome Measure Information:
Title
Frequency Distribution for Overall Tolerance at Visit 2 - Subject Rating
Description
The subject will rate how well he/she tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated.
Time Frame
Week 5 +/- 1 week
Title
Frequency Distribution for Overall Tolerance at Visit 2 - Investigator Rating
Description
The investigator will rate how well the participant tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated.
Time Frame
Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness
Description
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be completed for Skin Dryness. The question asks subjects to rate the severity of their dry skin at its worst over the last 7 days from None to Very Severe on a 5-point scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching
Description
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be completed for Itching. The question asks subjects to rate the severity of their itchy skin at its worst over the last 7 days from None to Very Severe on a 5-point scale. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Skindex-16 Global Score
Description
The Skindex-16 is a dermatology-specific quality of life measuring tool. (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days they have been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The global score is the average score for all questions and is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Skindex-16 Emotional Subscale
Description
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Emotional subscale looks at the average score of questions 5-11 regarding emotion; the emotional score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Skindex-16 Symptoms Subscale
Description
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Symptoms subscale looks at the average score of questions 1-4 individual responses regarding symptoms; the symptoms score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Skindex-16 Functional Subscale
Description
The Skindex-16 is a dermatology-specific quality of life measuring tool (The SKINDEX contact information and permission to use: Mapi Research Trust, Lyon, France. Internet: https://eprovide.mapi-trust.org). It contains 16 questions that ask subjects to rate how often over the last 7 days have they been bothered by various skin conditions on a scale of 0 (never bothered) to 6 (always bothered). The Functional subscale looks at the average score of questions 12 - 16 regarding daily functioning; the functional score is transformed to a linear scale ranging from 0 (never bothered) to 100 (always bothered) so a higher score indicates a lower quality of life. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Skin Moisture
Description
Skin moisture will be measured with a Corneometer, with values ranging from 0 (no moisture) to 120 (most moisturized) arbitrary units. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Skin Water Loss
Description
The amount of water lost through the skin will be measured with a Vapometer. Higher numbers indicate more water loss. Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Self-Assessment of Dryness
Description
Subjects will be asked to rate their overall skin dryness on a scale of 1 (very dry) to 10 (skin feels moisturized). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Self-Assessment of Flakiness
Description
Subjects will be asked to rate their overall skin flakiness on a scale of 1 (flaking very apparent) to 10 (no visible flaking). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Self-Assessment of Itchiness
Description
Subjects will be asked to rate their overall skin itchiness on a scale of 1 (very itchy) to 10 (not at all itchy). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 weeks).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Self-Assessment of Roughness
Description
Subjects will be asked to rate their overall skin roughness/texture on a scale of 1 (very rough) to 10 (not at all rough). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 weeks).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Self-Assessment of Smoothness
Description
Subjects will be asked to rate their overall skin smoothness on a scale of 1 (not at all smooth) to 10 (very smooth). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Self-Assessment of Softness
Description
Subjects will be asked to rate their overall skin softness on a scale of 1 (not at all soft) to 10 (very soft). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Self-Assessment of Comfort
Description
Subjects will be asked to rate their overall skin comfort on a scale of 1 (uncomfortable/irritated) to 10 (very comfortable/not at all irritated). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week
Title
Mean Change from Baseline to Visit 2 in Self-Assessment of Overall Look/Feel
Description
Subjects will be asked to rate the overall look and feel of their skin on a scale of 1 (not healthy looking) to 10 (healthy looking). Baseline will be compared to the subjects' final visit (Week 5 +/- 1 week).
Time Frame
Baseline to Week 5 +/- 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Lacouture, M.D.
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
IPD Sharing URL
http://yoda.yale.edu.
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Ilnytska O, Kaur S, Chon S, Reynertson KA, Nebus J, Garay M, Mahmood K, Southall MD. Colloidal Oatmeal <em>(Avena Sativa)</em> Improves Skin Barrier Through Multi-Therapy Activity. J Drugs Dermatol. 2016 Jun 1;15(6):684-90.
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Criquet M, Roure R, Dayan L, Nollent V, Bertin C. Safety and efficacy of personal care products containing colloidal oatmeal. Clin Cosmet Investig Dermatol. 2012;5:183-93. doi: 10.2147/CCID.S31375. Epub 2012 Nov 8.
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Links:
URL
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Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients

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