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Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097850
Recruitment Status : Withdrawn (No subject accrual.)
First Posted : April 2, 2010
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Hand Foot Skin Syndrome Drug: henna paste Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms
Study Start Date : March 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Right
Application of henna paste to right hand/foot plus CeraVe moisturizer
Drug: henna paste
Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet

Left
Application of henna paste to the left hand/foot plus CeraVe moisturizer
Drug: henna paste
Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet




Primary Outcome Measures :
  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. [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire [ Time Frame: 3 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01097850


Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Peter Lio, MD Northwestern University
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Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT01097850    
Other Study ID Numbers: NU 09D1
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Keywords provided by Dennis West, Northwestern University:
hand foot skin syndrome
palmar plantar erythrodysesthesia
doxorubicin
capecitabine
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes