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This study has been withdrawn prior to enrollment.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
  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:


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
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, see Learn About Clinical Studies.

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 July 23, 2014