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Skin Care for Cancer Patients: A Product Satisfaction Survey

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ClinicalTrials.gov Identifier: NCT00871429
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : August 10, 2010
Last Update Posted : March 17, 2015
Sponsor:
Information provided by:
Northwestern University

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.

Condition or disease Intervention/treatment Phase
Skin Toxicity Other: Lindi skin care products Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Selected Skin Products for Cancer Patients: A Product Satisfaction Survey
Study Start Date : March 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : August 2010

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)


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Mario Lacouture MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00871429     History of Changes
Other Study ID Numbers: MEL080108
First Posted: March 30, 2009    Key Record Dates
Results First Posted: August 10, 2010
Last Update Posted: March 17, 2015
Last Verified: February 2015

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