Clinical TrialID 1030
Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
NCT03796052
Ichthyosis|Pruritus
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 1030
- Evidence Id
- 1030
- Core Evidence Id
- 1030
- Source Clinical Trial Id
- 1012
- Herb2 Clinical Trial Id
- HBCT001012
- Nct Id
- NCT03796052
- Title
- Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Ichthyosis|Pruritus
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- OTHER: Avena Sativa Skincare Regimen
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 53
- Outcome Measure
- 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
- Sponsor Collaborator
- Johnson & Johnson Consumer Inc. (J&JCI)
- Funded By
- INDUSTRY
- Location
- Memorial Sloan-Kettering Cancer Center, New York, New York, 10022, United States
- Other Id
- CCSSKA000844
- Start Date
- 2019-05-23
- Primary Completion Date
- 2019-12-18
- Completion Date
- 2019-12-18
- First Posted
- 2019-01-08
- Results First Posted
- Last Update Posted
- 2020-11-04
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT03796052
- Title Cn
- Title En
- Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
- Bilingual Status
- semi_complete