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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796052
Recruitment Status : Completed
First Posted : January 8, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

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.

Condition or disease Intervention/treatment Phase
Ichthyosis Pruritus Other: Avena Sativa Skincare Regimen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 23, 2019
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Experimental: Avena Sativa Skincare Regimen
Avena sativa-containing body wash, body cream, and anti-itch balm
Other: Avena Sativa Skincare Regimen
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 Measures :
  1. Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  2. Mean Change from Baseline to Visit 2 in CTCAE Grading of Pruritus [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  3. Mean Change from Baseline to Visit 2 in Overall Xerosis Grading [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  4. Mean Change from Baseline to Visit 2 in Overall Pruritus Grading [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  5. Mean Change from Baseline to Visit 2 in Overall Irritation Assessment [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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 :
  1. Frequency Distribution for Overall Tolerance at Visit 2 - Subject Rating [ Time Frame: Week 5 +/- 1 week ]
    The subject will rate how well he/she tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated.

  2. Frequency Distribution for Overall Tolerance at Visit 2 - Investigator Rating [ Time Frame: Week 5 +/- 1 week ]
    The investigator will rate how well the participant tolerated the study regimen using the following choices: Well tolerated, tolerated, or not tolerated.

  3. Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  4. Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  5. Mean Change from Baseline to Visit 2 in Skindex-16 Global Score [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  6. Mean Change from Baseline to Visit 2 in Skindex-16 Emotional Subscale [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  7. Mean Change from Baseline to Visit 2 in Skindex-16 Symptoms Subscale [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  8. Mean Change from Baseline to Visit 2 in Skindex-16 Functional Subscale [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  9. Mean Change from Baseline to Visit 2 in Skin Moisture [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  10. Mean Change from Baseline to Visit 2 in Skin Water Loss [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  11. Mean Change from Baseline to Visit 2 in Self-Assessment of Dryness [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  12. Mean Change from Baseline to Visit 2 in Self-Assessment of Flakiness [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  13. Mean Change from Baseline to Visit 2 in Self-Assessment of Itchiness [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  14. Mean Change from Baseline to Visit 2 in Self-Assessment of Roughness [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  15. Mean Change from Baseline to Visit 2 in Self-Assessment of Smoothness [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  16. Mean Change from Baseline to Visit 2 in Self-Assessment of Softness [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  17. Mean Change from Baseline to Visit 2 in Self-Assessment of Comfort [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).

  18. Mean Change from Baseline to Visit 2 in Self-Assessment of Overall Look/Feel [ Time Frame: Baseline to Week 5 +/- 1 week ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796052


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10022
Sponsors and Collaborators
Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
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Principal Investigator: Mario Lacouture, M.D. Memorial Sloan Kettering Cancer Center
Additional Information:
Publications:
Common Terminology Criteria for Adverse Events (CTCAE). (2018, Mar 01). Retrieved from https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
The PRO-CTCAE Measurement System. (2018, Sep 14). Retrieved from https://healthcaredelivery.cancer.gov/pro-ctcae/measurement.html
Skin Conditions. (2012, Jun 26). Retrieved from https://www.cancer.net/navigating-cancer-care/side-effects/skin-conditions

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Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT03796052    
Other Study ID Numbers: CCSSKA000844
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://yoda.yale.edu.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):
Pruritis
Itching
Dryness
Xerosis
Additional relevant MeSH terms:
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Ichthyosis
Pruritus
Skin Diseases
Skin Manifestations
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Keratosis