Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

Last updated: April 27, 2025
Sponsor: Northwestern University
Overall Status: Active - Not Recruiting

Phase

1

Condition

Hair Loss

Alopecia

Treatment

oral minoxidil

Clinical Study ID

NCT03831334
JNC01142017
  • Ages > 18
  • All Genders

Study Summary

An open label, pilot study involving the use of low dose oral minoxidil to treat permanent chemotherapy-induced alopecia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a clinical diagnosis of permanent chemotherapy-induced alopecia whocompleted chemotherapy ≥ 6 months from the date of registration.

  • Patients must be age ≥ 18 years.

  • Females of child-bearing potential (FOCBP) and males must agree to use adequatecontraception (e.g., hormonal contraceptives such as birth control pills, patch,intrauterine device; barrier contraception such as male/female condoms, diaphragm;male partner with vasectomy; abstinence) prior to study entry, for the duration ofstudy participation, and for 30 days following completion of therapy.

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)

  • FOCBP must have a negative urine or serum pregnancy test within 7 days prior toregistration on study.

  • Patients must have the ability to understand and the willingness to sign a writteninformed consent prior to registration in the study.

Exclusion

Exclusion Criteria:

  • Patients receiving any other investigational agents or using other alopeciatreatments in the past 3 months are not eligible.

  • Patients currently undergoing systemic cancer treatment or within 6 months offinishing chemotherapy are not eligible. Note: Patients receiving hormone modulatorsare eligible.

  • Patients who have pheochromocytoma, hypothyroidism, anemia, cutaneous GVHD,hypotension, or a history of hypersensitivity to any components of the drugpreparation are not eligible.

  • Patients who have other forms of alopecia besides PCIA (with the exception of femalepattern Ludwig 1 alopecia) are not eligible.

  • Patients on oral or injectable anticoagulants are not eligible to participate in theoptional punch biopsy

  • Patients who have an uncontrolled intercurrent illness including, but not limited toany of the following, are not eligible: (Uncontrolled Hypertension, Ongoing oractive infection requiring systemic treatment, Symptomatic congestive heart failure,Unstable angina pectoris, Cardiac arrhythmia, Pericardial effusion, Psychiatricillness/social situations that would limit compliance with study requirements,Patients with any other illness or condition that the treating investigator feelswould interfere with study compliance or would compromise the patient's safety orstudy endpoints.)

  • Patients currently taking guanethidine are not eligible. Patients may participateafter a 1-week washout period.

  • Patients currently taking drugs that may enhance the hypotensive effect of minoxidilare not eligible. Please contact study team regarding specific drug as washoutperiod, as this will vary. Note: This includes: Alfuzosin, Amifostine, antipsychoticagents, Atazanavir, barbiturates, Benperidol, Brimonidine, Dapoxetine, Diazoxide,DULoxetine, Levodopa, Lormetazepam, Molsidomine, Naftopidil, Nicergoline,Nicorandil, Nitroprusside, Obinutuzumab, Pentoxifylline, phosphodiesterase 5inhibitors, Probenecid, prostacyclin analogues, Quinagolide, and Valproate. If apatient is currently taking any of these drugs, further evaluation will be requiredto determine eligibility.

  • Female patients who are pregnant or nursing are not eligible.

  • Patients who have any condition or situation which, in the investigator's opinion,puts the patient at significant risk, could confound the study results, or mayinterfere significantly with the patient's participation in the study are noteligible.

  • Patients who are unable to communicate or cooperate with the investigator due tolanguage problems, poor mental development, or impaired cerebral function are noteligible.

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: oral minoxidil
Phase: 1
Study Start date:
April 09, 2019
Estimated Completion Date:
August 31, 2025

Study Description

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.

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

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