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

Alopecia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00713154
• Other study ID #: Mito 02-02
• Status: Terminated
• Phase: Phase 2
• First received: July 9, 2008
• Last updated: July 10, 2008
• Start date: April 2007
• Est. completion date: September 2008

Study information

• Verified date: July 2008
• Source: Mitos Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• MTS-01
MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment
• Placebo
Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitos Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator assessment of hair loss using a 10 point scale		up to 12 weeks	No
Secondary	A time to event analysis of the hair loss		up to 12 weeks	No