Clinical trial · Interventional
Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
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
NCT03796052CI-TRIAL-00048084completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ichthyosis | — | UNRESOLVED | — |
| Pruritus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avena Sativa Skincare Regimen | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avena Sativa Skincare Regimen
- description
- Avena sativa-containing body wash, body cream, and anti-itch balm
- interventionNames
- Other: Avena Sativa Skincare Regimen
Primary outcomes (5)
- measure
- Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis
- timeFrame
- Baseline to Week 5 +/- 1 week
- 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).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (12)
- BACKGROUNDKurtz ES, Wallo W. Colloidal oatmeal: history, chemistry and clinical properties. J Drugs Dermatol. 2007 Feb;6(2):167-70. PMID 17373175
- BACKGROUNDFowler 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
- BACKGROUNDIlnytska 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
- BACKGROUNDSur 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
- BACKGROUNDCriquet 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
- BACKGROUNDOken 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
- BACKGROUNDElman 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
- BACKGROUNDChren 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.