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Henna paste for hand-foot skin syndrome
NCT01097850Phase 2
Key facts
- Status
- Withdrawn
- Start
- Mar 2010
- Primary completion
- Jan 2012
- Sponsor
- Northwestern University
- Modality
- Small Molecules
- Drugs
- henna
- Conditions
- Palmar-Plantar Erythrodysesthesia (PPE)
01
Overview
Phase 2, randomised, open-label trial of henna in Palmar-Plantar Erythrodysesthesia (PPE) (2 arms), sponsored by Northwestern University. Primary endpoint: Severity of hand-foot skin syndrome at 3 weeks. Planned start Mar 2010; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedOpen-label
Right side henna
Henna paste applied to the right hand/foot; CeraVe applied to both sides.
Left side henna
Henna paste applied to the left hand/foot; CeraVe applied to both sides.
03
Who it enrols
Patients 18+ with active hand-foot skin syndrome (Grade 1-3) from capecitabine or pegylated liposomal doxorubicin, without G6PD deficiency or henna allergy.
04
Endpoints
Primary
Severity of hand-foot skin syndrome
Secondary
Skindex-16
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