Skin Care for Cancer Patients: A Product Satisfaction Survey

NCT00871429 | Completed Results

• 1 other identifier: MEL080108
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Toxicity

Keywords

skin toxicity; cancer patients; adverse effects

Outcome Measures

Primary Outcomes (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)

  one month of use

Secondary Outcomes (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.

  one month

Interventions

Lindi skin care products OTHER

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).

Also known as: Lindi Skin soothing balm (product A), Lindi Skin face serum (product B), Lindi Skin face wash (product C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Haley AC, Calahan C, Gandhi M, West DP, Rademaker A, Lacouture ME. Skin care management in cancer patients: an evaluation of quality of life and tolerability. Support Care Cancer. 2011 Apr;19(4):545-54. doi: 10.1007/s00520-010-0851-8. Epub 2010 Mar 25.

  PMID: 20336328 BACKGROUND

Limitations and Caveats

No limitations of the trial identified.

Results Point of Contact

• Title: Mandy Browning
• Organization: Northwestern University

mandybrowning2015@u.northwestern.edu

312-695-6829

Study Officials

• Mario E Lacouture, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: August 1, 2010
• Last Updated: March 17, 2015
• Results First Posted: August 10, 2010

Record last verified: 2015-02

Locations

US (1)