An interventional study of Lindi skin care products in Skin Toxicity, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
This study is being done because the investigators would like to evaluate product satisfaction of three test products (product A, product B, product C) that are available at any drug store. This will be done by measuring any changes in the subjects' answers to the Skindex-16 questionnaire at two time points (at screening and baseline visit and at follow-up visit) and by evaluating their responses to the product satisfaction survey that will be given to them by a study coordinator.
The primary objective of this study is to evaluate product satisfaction of the following test articles A, B, and C: Lindi Skin soothing balm (product A), Lindi Skin face serum (product B), and Lindi Skin face wash (product C). This will be done by measuring change in Skindex-16 questionnaire at two time points (baseline and follow-up visits) and by evaluating responses to the investigator administered product satisfaction survey.
The secondary objective of this study is to see if there is any correlation between product satisfaction and grade of skin toxicity based on NCI-CTCAE v.3.0 scale.
Participants in this study will be patients seen at the Northwestern University SERIES clinic or Lurie Cancer Center who are receiving chemotherapeutic and or radiation treatments. Subjects who choose to participate complete a Skindex16 questionnaire, and will after consenting to participate, be given all three test articles A, B, and C to use daily for one month. (These test articles are currently marketed products classified by the FDA as cosmetics).
At the return visit, 1 month after baseline visit, the participant will be asked to return the test articles and complete an investigator administered product satisfaction questionnaire for each test article used. 100 participants will be surveyed. Subjects will be telephoned to check for product compliance after 1 week and 2 week intervals.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will then be instructed to apply all three products daily for 1 month. The products include: Lindi Skin soothing balm (product A), Lindi Skin face serum (product B, and Lindi Skin face wash (product C).
Also known as: Lindi Skin soothing balm (product A), Lindi Skin face serum (product B), Lindi Skin face wash (product C)
Product Satisfaction of the Following Test Articles A, B, and C: Lindi Skin Soothing Balm (Product A), Lindi Skin Face Serum (Product B), and Lindi Skin Face Wash (Product C)
Time frame: one month of use
Percentage of Subjects With Skin Toxicity Grades 0 to 5 Using The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 at Baseline Visit and 1 Month Follow-up After Using Lindi Products.
Time frame: one month
Participants in this study will be patients seen at the Northwestern University SERIES clinic or Lurie Cancer Center who are receiving chemotherapeutic and or radiation treatments.
| Milestone | Lindi Skin Participant Flow |
|---|---|
| Started | 99 |
| Completed | 75 |
| Not completed | 24 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Withdrawal by subject | 17 |
| Withdrew: Questionnaire not completed | 1 |
| Percentage of Participants | Lindi Skin Soothing Balm (Product A) | Lindi Skin Face Wash (Product C) | Lindi Skin Face Serum (Product B) |
|---|---|---|---|
| Participant Product Satisfaction: Very Good/Good | 78.67 | 73.68 | 88.31 |
| Participant Product Satisfaction: OK | 16.00 | 23.68 | 9.09 |
| Participant Product Satisfaction: Bad/Very Bad | 5.33 | 2.63 | 2.60 |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lindi Skin Soothing Balm (Product A) | — | — | — |
| Lindi Skin Face Wash (Product C) | — | — | — |
| Lindi Skin Face Serum (Product B) | — | — | — |
| Age, Categorical(Participants) | Cancer Patients Using Lindi Skin Products |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 99 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Cancer Patients Using Lindi Skin Products |
|---|---|
| Female | 94 |
| Male | 5 |
| Region of Enrollment(participants) | Cancer Patients Using Lindi Skin Products |
|---|---|
| United States | 99 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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