Permanent Chemotherapy-induced AlopeciaEarly Phase 1NCT03831334
Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
A Early Phase 1 study testing oral minoxidil in people with Permanent Chemotherapy-induced Alopecia, run by Northwestern University at 1 site in United States.
Trial summary
An open label, pilot study involving the use of low dose oral minoxidil to treat permanent chemotherapy-induced alopecia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Permanent Chemotherapy-induced Alopecia
- What is being tested?
- oral minoxidil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
An open label, pilot study involving the use of low dose oral minoxidil to treat permanent chemotherapy-induced alopecia.
Read the 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.
- Conditions
- Permanent Chemotherapy-induced Alopecia
- Being tested
- oral minoxidil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral minoxidilDrug
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 group | Role | What they receive |
|---|---|---|
| Minoxidil Treatment | Experimental | Low dose oral minoxidil Receives: Drug: oral minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 48 weeks
Secondary outcomes (1)
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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start9 Apr 2019
- Primary completion24 Jan 2024
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Permanent Chemotherapy-induced AlopeciaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Nam Choi, MD, Northwestern University
- Investigators
- Jennifer N Choi, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831334
- Sponsor's protocol ID
- JNC01142017
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2019
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
- ClinicalTrials.gov ID
- NCT03831334
- Acronym / sponsor ID
- JNC01142017
- Conditions
- Permanent Chemotherapy-induced Alopecia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minoxidil Treatment | Experimental | Drug: oral minoxidilLow dose oral minoxidil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral minoxidilParticipants 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. | Drug | Minoxidil Treatment |
Primary outcome
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
1 secondary outcome
Change in quality of life
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer N Choi, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing oral minoxidil in people with Permanent Chemotherapy-induced Alopecia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in degree of hair regrowth using the IPAQ scale (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.