- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01097850
Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome
December 11, 2014 updated by: Dennis West, Northwestern University
Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Right
Application of henna paste to right hand/foot plus CeraVe moisturizer
|
Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet
|
OTHER: Left
Application of henna paste to the left hand/foot plus CeraVe moisturizer
|
Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• 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.
Time Frame: 3 weeks
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Lio, MD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
March 31, 2010
First Submitted That Met QC Criteria
April 1, 2010
First Posted (ESTIMATE)
April 2, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
December 12, 2014
Last Update Submitted That Met QC Criteria
December 11, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU 09D1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hand Foot Skin Syndrome
-
Universitas SriwijayaActive, not recruitingCapecitabine | Hand and Foot Syndrome | Hand and Foot Skin ReactionIndonesia
-
Jessa HospitalHasselt UniversityRecruitingHand-foot Syndrome | Hand-foot Skin ReactionBelgium
-
China-Japan Friendship HospitalCompleted
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Quanta MedicalNAOS Institute of Life ScienceCompletedGrade 2 Hand-foot SyndromFrance
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Northwestern UniversityCompletedHand Foot Skin ReactionUnited States
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OnQuality Pharmaceuticals (USA) LLCActive, not recruitingHand-Foot Skin Reaction (HFSR)United States, China, India
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First People's Hospital of HangzhouZhejiang UniversityUnknownHand-Foot Skin Reaction (HFSR)China
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China Medical University HospitalNot yet recruiting
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHand-foot SyndromeChina
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