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

Mitos Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Alopecia

Treatments: Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01); Drug: alcohol-based gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00801086

MITO 02-03

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

MTS-01 (7% Tempol gel)

Treatment:

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

2

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: alcohol-based gel