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

Alopecia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00801086
• Other study ID #: MITO 02-03
• Status: Recruiting
• Phase: Phase 2
• First received: December 1, 2008
• Last updated: December 2, 2008
• Start date: November 2008
• Est. completion date: June 2010

Study information

• Verified date: December 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• 7% (w/v) Tempol alcohol-based gel (MTS-01)
200mL gel applied daily prior to radiation dose and removed immediately thereafter.
• alcohol-based gel
200mL gel applied daily prior to radiation dose and removed immediately thereafter

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mitos Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.		Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.	No