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Selected Skin Products for Cancer Patients: A Product Satisfaction Survey


N/A
18 Years
N/A
Not Enrolling
Both
Skin Toxicity

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Trial Information

Selected Skin Products for Cancer Patients: A Product Satisfaction Survey


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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)

Outcome Time Frame:

one month of use

Safety Issue:

No

Principal Investigator

Mario E Lacouture, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

MEL080108

NCT ID:

NCT00871429

Start Date:

March 2009

Completion Date:

August 2010

Related Keywords:

  • Skin Toxicity
  • skin toxicity
  • cancer patients
  • adverse effects

Name

Location

Northwestern University Department of DermatologyChicago, Illinois  60611