Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
کلید واژه ها
خلاصه
شرح
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.
تاریخ
| آخرین تأیید شده: | 12/31/2019 |
| اولین ارسال: | 01/03/2019 |
| ثبت نام تخمینی ارسال شد: | 01/03/2019 |
| اولین ارسال: | 01/07/2019 |
| آخرین بروزرسانی ارسال شده: | 01/26/2020 |
| آخرین به روزرسانی ارسال شده: | 01/28/2020 |
| تاریخ شروع مطالعه واقعی: | 05/22/2019 |
| تاریخ تخمین اولیه اولیه: | 12/17/2019 |
| تاریخ برآورد مطالعه: | 12/17/2019 |
شرایط یا بیماری
مداخله / درمان
Other: Avena Sativa Skincare Regimen
فاز
گروههای بازو
| بازو | مداخله / درمان |
|---|---|
| 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) |
معیارهای صلاحیت
| سنین واجد شرایط تحصیل | 18 Years به 18 Years |
| جنسیت واجد شرایط مطالعه | All |
| داوطلبان سالم را می پذیرد | آره |
| شاخص | 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. |
نتیجه
اقدامات اولیه
1. Mean Change from Baseline to Visit 2 in CTCAE Grading of Xerosis [Baseline to Week 5 +/- 1 week]
2. Mean Change from Baseline to Visit 2 in CTCAE Grading of Pruritus [Baseline to Week 5 +/- 1 week]
3. Mean Change from Baseline to Visit 2 in Overall Xerosis Grading [Baseline to Week 5 +/- 1 week]
4. Mean Change from Baseline to Visit 2 in Overall Pruritus Grading [Baseline to Week 5 +/- 1 week]
5. Mean Change from Baseline to Visit 2 in Overall Irritation Assessment [Baseline to Week 5 +/- 1 week]
اقدامات ثانویه
1. Frequency Distribution for Overall Tolerance at Visit 2 - Subject Rating [Week 5 +/- 1 week]
2. Frequency Distribution for Overall Tolerance at Visit 2 - Investigator Rating [Week 5 +/- 1 week]
3. Mean Change from Baseline to Visit 2 in PRO-CTCAE Skin Dryness [Baseline to Week 5 +/- 1 week]
4. Mean Change from Baseline to Visit 2 in PRO-CTCAE Itching [Baseline to Week 5 +/- 1 week]
5. Mean Change from Baseline to Visit 2 in Skindex-16 Global Score [Baseline to Week 5 +/- 1 week]
6. Mean Change from Baseline to Visit 2 in Skindex-16 Emotional Subscale [Baseline to Week 5 +/- 1 week]
7. Mean Change from Baseline to Visit 2 in Skindex-16 Symptoms Subscale [Baseline to Week 5 +/- 1 week]
8. Mean Change from Baseline to Visit 2 in Skindex-16 Functional Subscale [Baseline to Week 5 +/- 1 week]
9. Mean Change from Baseline to Visit 2 in Skin Moisture [Baseline to Week 5 +/- 1 week]
10. Mean Change from Baseline to Visit 2 in Skin Water Loss [Baseline to Week 5 +/- 1 week]
11. Mean Change from Baseline to Visit 2 in Self-Assessment of Dryness [Baseline to Week 5 +/- 1 week]
12. Mean Change from Baseline to Visit 2 in Self-Assessment of Flakiness [Baseline to Week 5 +/- 1 week]
13. Mean Change from Baseline to Visit 2 in Self-Assessment of Itchiness [Baseline to Week 5 +/- 1 week]
14. Mean Change from Baseline to Visit 2 in Self-Assessment of Roughness [Baseline to Week 5 +/- 1 week]
15. Mean Change from Baseline to Visit 2 in Self-Assessment of Smoothness [Baseline to Week 5 +/- 1 week]
16. Mean Change from Baseline to Visit 2 in Self-Assessment of Softness [Baseline to Week 5 +/- 1 week]
17. Mean Change from Baseline to Visit 2 in Self-Assessment of Comfort [Baseline to Week 5 +/- 1 week]
18. Mean Change from Baseline to Visit 2 in Self-Assessment of Overall Look/Feel [Baseline to Week 5 +/- 1 week]
