Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain - Full Text View

Sponsored by:	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

MedlinePlus related topics: Hair Diseases and Hair Loss

Drug Information available for: Ethanol

U.S. FDA Resources

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

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
1: Experimental 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.
2: Placebo Comparator 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

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

Keywords provided by Mitos Pharmaceuticals:

Alopecia
Hair loss
Radiation
Whole brain radiotherapy
Radiation-induced alopecia

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Skin Diseases
Alopecia
Ethanol

Additional relevant MeSH terms:

Hair Diseases
Hypotrichosis

ClinicalTrials.gov processed this record on January 16, 2009