Skin Toxicity Clinical Trial
Official title:
Selected Skin Products for Cancer Patients: A Product Satisfaction Survey
Verified date | February 2015 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | August 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects who are at least 18 years of age. - Subjects who have the willingness and ability to understand and provide informed consent to participate in the study and are able to communicate with the investigator. - Subjects who are seen in the SERIES clinic or Lurie Cancer Center and who are receiving chemotherapy and/or radiation treatment for malignancy - Subjects who have grade <2 skin toxicity based on NCI-CTCAE v3.0 scale. - Subjects who are routine cosmetics users Exclusion Criteria: - Under 18 years of age. - Known allergy to any of the ingredients in the assigned products (Appendix C). - Subjects who have grade 2,3,4 skin toxicity based on NCI-CTCAE v3.0 scale. - Subjects who are pregnant, breast feeding, or those who are planning on becoming pregnant during test period. - Subjects who use multiple topical agents on study areas |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Department of Dermatology | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Haley AC, Calahan C, Gandhi M, West DP, Rademaker A, Lacouture ME. Skin care management in cancer patients: an evaluation of quality of life and tolerability. Support Care Cancer. 2011 Apr;19(4):545-54. doi: 10.1007/s00520-010-0851-8. Epub 2010 Mar 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | one month of use | No | |
Secondary | 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. | one month | No |
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