Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03831334 |
Recruitment Status :
Recruiting
First Posted : February 5, 2019
Last Update Posted : January 13, 2023
|
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Jennifer Nam Choi, MD, Northwestern University
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | January 25, 2019 | ||||||||
First Posted Date ICMJE | February 5, 2019 | ||||||||
Last Update Posted Date | January 13, 2023 | ||||||||
Actual Study Start Date ICMJE | April 9, 2019 | ||||||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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 Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | 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 ICMJE | Early Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A 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 ICMJE | 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 | Recruiting | ||||||||
Estimated Enrollment ICMJE |
25 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 2024 | ||||||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | 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:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
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 |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Current Responsible Party | Jennifer Nam Choi, MD, Northwestern University | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Northwestern University | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Northwestern University | ||||||||
Verification Date | January 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |