Hand Foot Skin Syndrome Clinical Trial
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
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 2012 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Northwestern University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | • 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. | 3 weeks | Yes | |
| Secondary | To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire | 3 weeks | No |