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
18 Years
N/A
Both
Alopecia
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.
Outcome Time Frame:
Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.
Safety Issue:
No
Principal Investigator
James Metz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
MITO 02-03
NCT ID:
NCT00801086
Start Date:
November 2008
Completion Date:
June 2010
Related Keywords:
- Alopecia
- Alopecia
- Hair loss
- Radiation
- Whole brain radiotherapy
- Radiation-induced alopecia
- Alopecia
- Alopecia Areata
Name | Location |
|---|---|
| University of Arizona | Tucson, Arizona 85724 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
