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

Status

Withdrawn

Intervention / Treatment

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.

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.

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