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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2008 by Mitos Pharmaceuticals. Recruitment status was Recruiting

First Received on December 1, 2008. Last Updated on December 2, 2008 History of Changes

Sponsor:	Mitos Pharmaceuticals
Information provided by:	Mitos Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00801086

Purpose

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
Alopecia	Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01) Drug: alcohol-based gel	Phase II

Study Type:	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
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

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by Mitos Pharmaceuticals:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801086

Locations

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

Investigators

Study Chair:

James Metz, MD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Louis Habash/ President and CEO, Mitos Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00801086 History of Changes
Other Study ID Numbers:	MITO 02-03
Study First Received:	December 1, 2008
Last Updated:	December 2, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mitos Pharmaceuticals:

Alopecia
Hair loss
Radiation
Whole brain radiotherapy
Radiation-induced alopecia

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Ethanol
Tempol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Radiation-Protective Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on February 09, 2012