Study Stopped
No subject accrual.
Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome
Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether henna paste is effective in the treatment of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal doxorubicin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 12, 2014
December 1, 2014
1.8 years
March 31, 2010
December 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side.
3 weeks
Secondary Outcomes (1)
To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire
3 weeks
Study Arms (2)
Right
OTHERApplication of henna paste to right hand/foot plus CeraVe moisturizer
Left
OTHERApplication of henna paste to the left hand/foot plus CeraVe moisturizer
Interventions
Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet
Eligibility Criteria
You may qualify if:
- Patients receiving capecitabine and/or pegylated liposomal doxorubicin as monotherapy or in combination with other agents
- New diagnosis of active hand-foot skin reaction (on bilateral hands and/or bilateral feet) of 1-3 toxicity as defined by the NCI-CTCAE version 4.0 grading scale with onset of symptoms within the last thirty days
- Patients must be 18 years or older
- Patients must provide written informed consent to participate in the study
You may not qualify if:
- Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
- Known allergy to natural henna
- Patients with a previous history of HFS
- History of G6PD deficiency as determined by screening bloodwork
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Lio, MD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Dermatology and Pediatrics
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 2, 2010
Study Start
March 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
December 12, 2014
Record last verified: 2014-12