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

NCT00801086 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2008-12-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Mitos Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • James Metz, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-12-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00801086 on ClinicalTrials.gov