NCT00713154

Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy

A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Mitos Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy

Detailed description

Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy

Conditions

• Alopecia

Interventions

Type	Name	Description
DRUG	MTS-01	MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment
DRUG	Placebo	Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-09-01
• Completion: 2008-09-01
• First posted: 2008-07-11
• Last updated: 2008-07-11