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Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome

This study has been withdrawn prior to enrollment.
(No subject accrual.)
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT01097850
First received: March 31, 2010
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Hand Foot Skin Syndrome
 Drug: henna paste
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097850

Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Peter Lio, MD Northwestern University
  More Information

No publications provided

Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT01097850     History of Changes
Other Study ID Numbers: NU 09D1
Study First Received: March 31, 2010
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Northwestern University:
hand foot skin syndrome
palmar plantar erythrodysesthesia
doxorubicin
capecitabine

Additional relevant MeSH terms:
Lawsone
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013