Skin Care for Cancer Patients: A Product Satisfaction Survey
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Selected Skin Products for Cancer Patients: A Product Satisfaction Survey|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Other: Lindi skin care products
- Lindi Skin soothing balm (product A)
- Lindi Skin face serum (product B)
- Lindi Skin face wash (product C)
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871429
|United States, Illinois|
|Northwestern University Department of Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Mario E Lacouture, MD||Northwestern University|