Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome

Northwestern University

Status and phase

Withdrawn

Phase 2

Conditions

Hand Foot Skin Syndrome

Treatments

Drug: henna paste

Study type

Interventional

Funder types

Other

Identifiers

NCT01097850

NU 09D1

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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