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An open label, pilot study involving the use of low dose oral minoxidil to treat permanent chemotherapy-induced alopecia.
Patients will be evaluated through clinical assessment, histology, quality of life assessment, and adverse event monitoring. The data gathered from this study will be used to determine the safety and efficacy of the treatment regimen for this subset of CIA patients. The oral minoxidil regimen will be considered effective if significant clinical regrowth, positive histological changes, and improved Quality of Life are reported after the onset of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minoxidil Treatment | Experimental | Low dose oral minoxidil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral minoxidil | Drug | Participants will be provided with minoxidil (2.5 mg tablets) for 90 days (45 tablets + 5 extra in case of splitting difficulty) of treatment drug in dispensing containers and instructed to take half a pill (1.25mg), once a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in degree of hair regrowth using the IPAQ scale | Evaluation will be performed by the investigators at each visit (every 12 weeks) as measured by the Investigator Photographic Assessment Questionnaire (IPAQ) | 48 weeks |
| Change in degree of hair regrowth using the Dean Scale | Evaluation will be performed by the investigators at each visit (every 12 weeks) as measured by the Dean Scale | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Evaluation will be performed by the investigators at every other visit (every 24 weeks) until the end of the study (48 weeks total).The quality of life endpoint will be assessed with the Dermatology Life Quality Index (DLQI) as reported by the subject. | 48 weeks |
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Inclusion Criteria:
Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer N Choi, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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