Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome

• Status: Withdrawn
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Lawsone

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