N/A
N=99
Skin Care for Cancer Patients: A Product Satisfaction Survey
Skin Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT00871429 ↗Enrolled (actual)
99
Serious AEs
—
Results posted
Aug 2010
Primary outcome: 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) — 78.67; 73.68; 88.31; 16.00 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lindi skin care products (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
78.67; 73.68; 88.31; 16.00; 23.68; 9.09 | — |
| 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. |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00871429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.