Alopecia
Conditions
Keywords
Alopecia, Hair loss, Radiation, Whole brain radiotherapy, Radiation-induced alopecia
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.
Interventions
DRUG7% (w/v) Tempol alcohol-based gel (MTS-01)
200mL gel applied daily prior to radiation dose and removed immediately thereafter.
DRUGalcohol-based gel
200mL gel applied daily prior to radiation dose and removed immediately thereafter
Sponsors
Mitos Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Outcome results
None listed