Skin Care for Cancer Patients: A Product Satisfaction Survey

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00871429
First received: March 26, 2009
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Skin Toxicity
Other: Lindi skin care products

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: March 2009
Study Completion Date: August 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Lindi 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).

    Other Names:
    • Lindi Skin soothing balm (product A)
    • Lindi Skin face serum (product B)
    • Lindi Skin face wash (product C)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871429

Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Mario E Lacouture, MD Northwestern University
  More Information

Publications:
Responsible Party: Mario Lacouture MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00871429     History of Changes
Other Study ID Numbers: MEL080108
Study First Received: March 26, 2009
Results First Received: May 5, 2010
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
skin toxicity
cancer patients
adverse effects

ClinicalTrials.gov processed this record on August 28, 2014