Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome

This study has been withdrawn prior to enrollment.
(No subject accrual.)
Information provided by (Responsible Party):
Dennis West, Northwestern University Identifier:
First received: March 31, 2010
Last updated: December 11, 2014
Last verified: December 2014
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
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
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01097850

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

Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University Identifier: NCT01097850     History of Changes
Other Study ID Numbers: NU 09D1 
Study First Received: March 31, 2010
Last Updated: December 11, 2014
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

Additional relevant MeSH terms:
Pathologic Processes processed this record on May 26, 2016