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

NCT03796052 | Completed

• 1 other identifier: CCSSKA000844
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Ichthyosis; Pruritus

Keywords

Pruritis; Itching; Dryness; Xerosis

Outcome Measures

Primary Outcomes (5)

• 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).

  Baseline to 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).

  Baseline to 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).

  Baseline to 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).

  Baseline to 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).

  Baseline to Week 5 +/- 1 week

Secondary Outcomes (18)

• Frequency Distribution for Overall Tolerance at Visit 2 - Subject Rating

  Week 5 +/- 1 week

• Frequency Distribution for Overall Tolerance at Visit 2 - Investigator Rating

  Week 5 +/- 1 week

• Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness

  Baseline to Week 5 +/- 1 week

• Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching

  Baseline to Week 5 +/- 1 week

• Mean Change from Baseline to Visit 2 in Skindex-16 Global Score

  Baseline to Week 5 +/- 1 week

Study Arms (1)

Avena Sativa Skincare Regimen

EXPERIMENTAL

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

Other: Avena Sativa Skincare Regimen

Interventions

Avena Sativa Skincare Regimen OTHER

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)

Avena Sativa Skincare Regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10022, United States

Location

Related Publications (12)

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

  PMID: 17373175 BACKGROUND

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

  PMID: 25607551 BACKGROUND

• 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.

  PMID: 27272074 BACKGROUND

• 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.

  PMID: 18461339 BACKGROUND

• 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.

  PMID: 23204849 BACKGROUND

• 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.

  PMID: 7165009 BACKGROUND

• 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.

  PMID: 19995367 BACKGROUND

• 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.

  PMID: 11443481 BACKGROUND

• Common Terminology Criteria for Adverse Events (CTCAE). (2018, Mar 01). Retrieved from https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm

  BACKGROUND

• The PRO-CTCAE Measurement System. (2018, Sep 14). Retrieved from https://healthcaredelivery.cancer.gov/pro-ctcae/measurement.html

  BACKGROUND

• 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.

  PMID: 26994263 BACKGROUND

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

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Ichthyosis; Pruritus

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mario Lacouture, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive the same study regimen consisting of 3 products: a body wash, a body cream, and an anti-itch balm.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: May 23, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)