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Sponsored by: |
Mitos Pharmaceuticals |
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Information provided by: | Mitos Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00801086 |
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.
Condition | Intervention | Phase |
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Alopecia |
Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01) Drug: alcohol-based gel |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 16 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MTS-01 (7% Tempol gel)
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Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)
200mL gel applied daily prior to radiation dose and removed immediately thereafter.
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2: Placebo Comparator
Vehicle
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Drug: alcohol-based gel
200mL gel applied daily prior to radiation dose and removed immediately thereafter
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
University of Arizona | Recruiting |
Tucson, Arizona, United States, 85724 | |
Contact: Jamie Holt 520-694-6000 ext 2970 | |
Principal Investigator: Baldassarre Stea, MD,PhD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Deborah Smith, RN 215-662-6694 | |
Principal Investigator: Jim Metz, MD |
Study Chair: | James Metz, MD | University of Pennsylvania |
Responsible Party: | Mitos Pharmaceuticals, Inc. ( Louis Habash/ President and CEO ) |
Study ID Numbers: | MITO 02-03 |
Study First Received: | December 1, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00801086 |
Health Authority: | United States: Food and Drug Administration |
Alopecia Hair loss Radiation Whole brain radiotherapy Radiation-induced alopecia |
Pathological Conditions, Anatomical Skin Diseases Alopecia Ethanol |
Hair Diseases Hypotrichosis |