Recruiting
Phase 2

Tempol

Sponsor:

Mitos Pharmaceuticals

Code:

NCT00801086

Conditions

Alopecia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

7% (w/v) Tempol alcohol-based gel (MTS-01)

alcohol-based gel

Study Details

Brief 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.

Conditions

Alopecia

Study ID

NCT00801086

Start date

Nov, 2008

Status verified date

Dec, 2008

Completion date

Jun, 2010

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 1

MTS-01 (7% Tempol gel)

placebo comparator: 2

Vehicle

Interventions

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Jamie Holt

520-694-6000

Principal Investigator:

Baldassarre Stea, MD,PhD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Deborah Smith, RN

215-662-6694

Principal Investigator:

Jim Metz, MD

More Information

Sponsor

Mitos Pharmaceuticals

Last update posted

Dec 3, 2008

Last verified

Dec, 2008

Keywords

  • Alopecia
  • Hair loss
  • Radiation
  • Whole brain radiotherapy
  • Radiation-induced alopecia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mitos Pharmaceuticals on 2008-12-03.