NCT00801086

Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain

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

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

Summary

Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.

Conditions

• Alopecia

Interventions

Type	Name	Description
DRUG	7% (w/v) Tempol alcohol-based gel (MTS-01)	200mL gel applied daily prior to radiation dose and removed immediately thereafter.
DRUG	alcohol-based gel	200mL gel applied daily prior to radiation dose and removed immediately thereafter

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-12-01
• Completion: 2010-06-01
• First posted: 2008-12-03
• Last updated: 2008-12-03

Locations

2 sites across 1 country: United States