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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00713154

Enrollment

Registered

2008-07-11

Start date

2007-04-30

Completion date

2008-09-30

Last updated

2008-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia

Keywords

Radiotherapy, induced

Brief summary

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

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

Interventions

DRUGMTS-01

MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment

DRUGPlacebo

Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Investigator assessment of hair loss using a 10 point scale	up to 12 weeks

Secondary

Measure	Time frame
A time to event analysis of the hair loss	up to 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026