Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy - Full Text View

Sponsored by:	Mitos Pharmaceuticals
Information provided by:	Mitos Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00713154

Purpose

The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy

Condition	Intervention	Phase
Alopecia	Drug: MTS-01 Drug: Placebo	Phase II

MedlinePlus related topics: Hair Diseases and Hair Loss

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

Further study details as provided by Mitos Pharmaceuticals:

Primary Outcome Measures:

Investigator assessment of hair loss using a 10 point scale [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A time to event analysis of the hair loss [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	April 2007
Estimated Study Completion Date:	September 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo group	Drug: Placebo Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment
2: Active Comparator Control Group	Drug: MTS-01 MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment

Detailed Description:

Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy

Eligibility

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

Criteria

Inclusion Criteria:

is >/= 18 years of age
Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required
Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol
has signed the HIPAA authorization

Exclusion Criteria:

-

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Mitos Pharmaceuticals, Inc. ( Louis Habash/ President and CEO )
Study ID Numbers:	Mito 02-02
Study First Received:	July 9, 2008
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00713154
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mitos Pharmaceuticals:

Radiotherapy
induced

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Skin Diseases
Alopecia

Additional relevant MeSH terms:

Hair Diseases
Hypotrichosis

ClinicalTrials.gov processed this record on January 14, 2009