Skin ToxicityNCT00871429
Skin Care for Cancer Patients: A Product Satisfaction Survey
A study testing Lindi skin care products in people with Skin Toxicity, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Toxicity
- What is being tested?
- Lindi skin care products
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Selected Skin Products for Cancer Patients: A Product Satisfaction Survey
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.
Read the 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.
- Conditions
- Skin Toxicity
- Being tested
- Lindi skin care products
- Keywords
- skin toxicity, cancer patients, adverse effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lindi skin care productsOther
Also called Lindi Skin soothing balm (product A), Lindi Skin face serum (product B), Lindi Skin face wash (product C)
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin ToxicityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Investigators
- Mario E Lacouture, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871429
- Sponsor's protocol ID
- MEL080108
- Status last verified
- Feb 2015
- First submitted
- 26 Mar 2009
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20336328
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selected Skin Products for Cancer Patients: A Product Satisfaction Survey
- ClinicalTrials.gov ID
- NCT00871429
- Acronym / sponsor ID
- MEL080108
- Conditions
- Skin Toxicity
- Keywords
- skin toxicity, cancer patients, adverse effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 10 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lindi skin care productsAlso: Lindi Skin soothing balm (product A), Lindi Skin face serum (product B), Lindi Skin face wash (product C)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 | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20336328Haley 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.
Related trials for Skin Toxicity
Enrolling by invitationObservational study
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Melanoma, Adenocarcinoma
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingPhase 1
Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
Melanoma
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
RecruitingPhase 3
S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
Cardiotoxicity, HER2/Neu Positive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario E Lacouture, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lindi skin care products in people with Skin Toxicity, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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) (time frame: one month of use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.