Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
NCT ID: NCT03796052
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2019-05-23
2019-12-18
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Avena Sativa Skincare Regimen
Avena sativa-containing body wash, body cream, and anti-itch balm
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Mario Lacouture, M.D.
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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References
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Kurtz ES, Wallo W. Colloidal oatmeal: history, chemistry and clinical properties. J Drugs Dermatol. 2007 Feb;6(2):167-70.
Fowler JF Jr. Colloidal oatmeal formulations and the treatment of atopic dermatitis. J Drugs Dermatol. 2014 Oct;13(10):1180-3; quiz 1184-5.
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.
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.
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.
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.
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.
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.
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.
Skin Conditions. (2012, Jun 26). Retrieved from https://www.cancer.net/navigating-cancer-care/side-effects/skin-conditions
Related Links
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Other Identifiers
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CCSSKA000844
Identifier Type: -
Identifier Source: org_study_id