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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801086
Recruitment Status : Unknown
Verified December 2008 by Mitos Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : December 3, 2008
Last Update Posted : December 3, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Alopecia Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01) Drug: alcohol-based gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : November 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
MTS-01 (7% Tempol gel)
Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)
200mL gel applied daily prior to radiation dose and removed immediately thereafter.

Placebo Comparator: 2
Drug: alcohol-based gel
200mL gel applied daily prior to radiation dose and removed immediately thereafter

Primary Outcome Measures :
  1. Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo. [ Time Frame: Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801086

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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         
Sponsors and Collaborators
Mitos Pharmaceuticals
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Study Chair: James Metz, MD University of Pennsylvania
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Responsible Party: Louis Habash/ President and CEO, Mitos Pharmaceuticals, Inc. Identifier: NCT00801086    
Other Study ID Numbers: MITO 02-03
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: December 3, 2008
Last Verified: December 2008
Keywords provided by Mitos Pharmaceuticals:
Hair loss
Whole brain radiotherapy
Radiation-induced alopecia
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Radiation-Protective Agents
Neuroprotective Agents