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

• ClinicalTrials.gov Identifier: NCT03831334
• Recruitment Status: Recruiting
• First Posted: February 5, 2019
• Last Update Posted: May 7, 2019
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Jennifer Nam Choi, MD, Northwestern University

Tracking Information

• First Submitted Date: January 25, 2019
• First Posted Date: February 5, 2019
• Last Update Posted Date: May 7, 2019
• Actual Study Start Date: April 9, 2019
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 3, 2019)

• Change in degree of hair regrowth using the IPAQ scale [ Time Frame: 48 weeks ]
  Evaluation will be performed by the investigators at each visit (every 12 weeks) as measured by the Investigator Photographic Assessment Questionnaire (IPAQ)
• Change in degree of hair regrowth using the Dean Scale [ Time Frame: 48 weeks ]
  Evaluation will be performed by the investigators at each visit (every 12 weeks) as measured by the Dean Scale

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 3, 2019)

Change in quality of life [ Time Frame: 48 weeks ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
• Official Title: An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
• Brief Summary: An open label, pilot study involving the use of low dose oral minoxidil to treat permanent chemotherapy-induced alopecia.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Permanent Chemotherapy-induced Alopecia

Intervention

Drug: oral minoxidil

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.

Study Arms

Experimental: Minoxidil Treatment

Low dose oral minoxidil

Intervention: Drug: oral minoxidil

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 3, 2019): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with a clinical diagnosis of permanent chemotherapy-induced alopecia who completed 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 adequate contraception (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 of study 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 to registration on study.
• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration in the study.

Exclusion Criteria:

• Patients receiving any other investigational agents or using other alopecia treatments in the past 3 months are not eligible.
• Patients currently undergoing systemic cancer treatment or within 6 months of finishing chemotherapy are not eligible. Note: Patients receiving hormone modulators are eligible.
• Patients who have pheochromocytoma, hypothyroidism, anemia, cutaneous GVHD, hypotension, or a history of hypersensitivity to any components of the drug preparation are not eligible.
• Patients who have other forms of alopecia besides PCIA (with the exception of female pattern Ludwig 1 alopecia) are not eligible.
• Patients on oral or injectable anticoagulants are not eligible to participate in the optional punch biopsy
• Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible: (Uncontrolled Hypertension, Ongoing or active infection requiring systemic treatment, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, Pericardial effusion, Psychiatric illness/social situations that would limit compliance with study requirements, Patients with any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.)
• Patients currently taking guanethidine are not eligible. Patients may participate after a 1-week washout period.
• Patients currently taking drugs that may enhance the hypotensive effect of minoxidil are not eligible. Please contact study team regarding specific drug as washout period, as this will vary. Note: This includes: Alfuzosin, Amifostine, antipsychotic agents, Atazanavir, barbiturates, Benperidol, Brimonidine, Dapoxetine, Diazoxide, DULoxetine, Levodopa, Lormetazepam, Molsidomine, Naftopidil, Nicergoline, Nicorandil, Nitroprusside, Obinutuzumab, Pentoxifylline, phosphodiesterase 5 inhibitors, Probenecid, prostacyclin analogues, Quinagolide, and Valproate. If a patient is currently taking any of these drugs, further evaluation will be required to 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 may interfere significantly with the patient's participation in the study are not eligible.
• Patients who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jennifer N Choi, MD; 312-695-8106; jennifer.choi@northwestern.edu

Contact: DermCTU; 312-504-5944; NUdermatologyCTU@northwestern.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03831334
• Other Study ID Numbers: JNC01142017
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Jennifer Nam Choi, MD, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jennifer N Choi, MD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: May 2019