Skin Toxicity
Conditions
Keywords
skin toxicity, cancer patients, adverse effects
Brief 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.
Detailed description
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.
Interventions
OTHERLindi skin care products
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).
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cancer Patients Using Lindi Skin Products | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Questionnaire not completed | 1 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Cancer Patients Using Lindi Skin Products |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants |
| Region of Enrollment United States | 99 participants |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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)
Time frame: one month of use
Population: the number of participants for analysis was determined per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lindi Skin Soothing Balm (Product A) | 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) | Participant Product Satisfaction: OK | 16.00 Percentage of Participants |
| Lindi Skin Soothing Balm (Product A) | 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) | Participant Product Satisfaction: Very Good/Good | 78.67 Percentage of Participants |
| Lindi Skin Soothing Balm (Product A) | 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) | Participant Product Satisfaction: Bad/Very Bad | 5.33 Percentage of Participants |
| 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) | Participant Product Satisfaction: OK | 23.68 Percentage of Participants |
| 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) | Participant Product Satisfaction: Very Good/Good | 73.68 Percentage of Participants |
| 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) | Participant Product Satisfaction: Bad/Very Bad | 2.63 Percentage of Participants |
| Lindi Skin Face Serum (Product B) | 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) | Participant Product Satisfaction: Very Good/Good | 88.31 Percentage of Participants |
| Lindi Skin Face Serum (Product B) | 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) | Participant Product Satisfaction: Bad/Very Bad | 2.60 Percentage of Participants |
| Lindi Skin Face Serum (Product B) | 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) | Participant Product Satisfaction: OK | 9.09 Percentage of Participants |
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.
Time frame: one month