Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain
Phase 2
- Conditions
- Alopecia
- Interventions
- Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)Drug: alcohol-based gel
- Registration Number
- NCT00801086
- Lead Sponsor
- Mitos Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended.
- Hair that covers the scalp and is at least 1/4 inch in length
Exclusion Criteria
- Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
- Pre-existing alopecia
- Previous brain radiotherapy
- scalp metastases or scalp wounds
- use of hair dyes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 7% (w/v) Tempol alcohol-based gel (MTS-01) MTS-01 (7% Tempol gel) 2 alcohol-based gel Vehicle
- Primary Outcome Measures
Name Time Method Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo. Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Arizona
🇺🇸Tucson, Arizona, United States