An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

Tracking Information
First Submitted Date ICMJE	January 25, 2019
First Posted Date ICMJE	February 5, 2019
Last Update Posted Date	February 5, 2019
Estimated Study Start Date ICMJE	March 2019
Estimated Primary Completion Date	December 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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 ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (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 ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Early Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Permanent Chemotherapy-induced Alopecia
Intervention ICMJE	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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Not yet recruiting
Estimated Enrollment ICMJE; (submitted: February 3, 2019)	25
Original Estimated Enrollment ICMJE	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 ICMJE	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 ICMJE	Contact: Jennifer N Choi, MD 312-695-8106 jennifer.choi@northwestern.edu Contact: DermCTU 312-504-5944 NUdermatologyCTU@northwestern.edu
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT03831334
Other Study ID Numbers ICMJE	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 ICMJE	Northwestern University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Jennifer N Choi, MD Northwestern University
PRS Account	Northwestern University
Verification Date	February 2019
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP