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IchthyosisNCT03796052

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

A study testing Avena Sativa Skincare Regimen in people with Ichthyosis and Pruritus, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ichthyosis, Pruritus
What is being tested?
Avena Sativa Skincare Regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
23 May 2019to 18 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10022

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Ichthyosis, Pruritus
Being tested
Avena Sativa Skincare Regimen
Keywords
Pruritis, Itching, Dryness, Xerosis
Medical subject headings
Ichthyosis, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avena Sativa Skincare RegimenOther

    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)

Study groups in NCT03796052
Study groupRoleWhat they receive
Avena Sativa Skincare RegimenExperimentalAvena sativa-containing body wash, body cream, and anti-itch balm
Receives: Other: Avena Sativa Skincare Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline to Week 5 +/- 1 week

  2. 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).

    Measured: Baseline to Week 5 +/- 1 week

  3. 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).

    Measured: Baseline to Week 5 +/- 1 week

  4. 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).

    Measured: Baseline to Week 5 +/- 1 week

  5. 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).

    Measured: Baseline to Week 5 +/- 1 week

Secondary outcomes (18)

  1. 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.

    Measured: Week 5 +/- 1 week

  2. 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.

    Measured: Week 5 +/- 1 week

  3. 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).

    Measured: Baseline to Week 5 +/- 1 week

  4. 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).

    Measured: Baseline to Week 5 +/- 1 week

  5. 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).

    Measured: Baseline to Week 5 +/- 1 week

  6. 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).

    Measured: Baseline to Week 5 +/- 1 week

  7. 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).

    Measured: Baseline to Week 5 +/- 1 week

  8. 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).

    Measured: Baseline to Week 5 +/- 1 week

  9. 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).

    Measured: Baseline to Week 5 +/- 1 week

  10. 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).

    Measured: Baseline to Week 5 +/- 1 week

  11. 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).

    Measured: Baseline to Week 5 +/- 1 week

  12. 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).

    Measured: Baseline to Week 5 +/- 1 week

  13. 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).

    Measured: Baseline to Week 5 +/- 1 week

  14. 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).

    Measured: Baseline to Week 5 +/- 1 week

  15. 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).

    Measured: Baseline to Week 5 +/- 1 week

  16. 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).

    Measured: Baseline to Week 5 +/- 1 week

  17. 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).

    Measured: Baseline to Week 5 +/- 1 week

  18. 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).

    Measured: Baseline to Week 5 +/- 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2019
  2. Study start23 May 2019
  3. Primary completion18 Dec 2019
  4. Study completion18 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03796052
Sponsor's protocol ID
CCSSKA000844
Status last verified
Oct 2020
First submitted
4 Jan 2019
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Kurtz ES, Wallo W. Colloidal oatmeal: history, chemistry and clinical properties. J Drugs Dermatol. 2007 Feb;6(2):167-70.

    PubMed 17373175

  • Fowler JF Jr. Colloidal oatmeal formulations and the treatment of atopic dermatitis. J Drugs Dermatol. 2014 Oct;13(10):1180-3; quiz 1184-5.

    PubMed 25607551

  • 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.

    PubMed 27272074

  • Sur R, Nigam A, Grote D, Liebel F, Southall MD. Avenanthramides, polyphenols from oats, exhibit anti-inflammatory and anti-itch activity. Arch Dermatol Res. 2008 Nov;300(10):569-74. doi: 10.1007/s00403-008-0858-x. Epub 2008 May 7.

    PubMed 18461339

  • 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.

    PubMed 23204849

  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009

  • Elman S, Hynan LS, Gabriel V, Mayo MJ. The 5-D itch scale: a new measure of pruritus. Br J Dermatol. 2010 Mar;162(3):587-93. doi: 10.1111/j.1365-2133.2009.09586.x. Epub 2009 Dec 1.

    PubMed 19995367

  • Chren MM, Lasek RJ, Sahay AP, Sands LP. Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg. 2001 Mar-Apr;5(2):105-10. doi: 10.1007/BF02737863. Epub 2001 Mar 21.

    PubMed 11443481

  • 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

  • Blume-Peytavi U, Kottner J, Sterry W, Hodin MW, Griffiths TW, Watson RE, Hay RJ, Griffiths CE. Age-Associated Skin Conditions and Diseases: Current Perspectives and Future Options. Gerontologist. 2016 Apr;56 Suppl 2:S230-42. doi: 10.1093/geront/gnw003.

    PubMed 26994263

  • Skin Conditions. (2012, Jun 26). Retrieved from https://www.cancer.net/navigating-cancer-care/side-effects/skin-conditions

Questions about this trial

What is this clinical trial studying?

A study testing Avena Sativa Skincare Regimen in people with Ichthyosis and Pruritus, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis (time frame: Baseline to Week 5 +/- 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03796052, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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