Survivors of Childhood CancerPhase 2NCT05778825
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
A Phase 2 study testing Oral Minoxidil in people with Survivors of Childhood Cancer and Alopecia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Survivors of Childhood Cancer, Alopecia
- What is being tested?
- Oral Minoxidil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to Mar 2027
- Phase
- Phase 2
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have been diagnosed with cancer before the age of 17.
- They must have completed either systemic or radiation therapy (cytotoxic chemotherapy and external beam radiation therapy) for their cancer at least 1 year prior to study entry.
- They must be between 6-18 years old at the time of enrollment.
- They must have a clinical diagnosis of persistent or late alopecia for >6 months and that is definitely, probably, or possibly related to prior chemotherapy and/or radiation.
Who cannot join
- Had a history of alopecia prior to systemic or radiation therapy for cancer, or has alopecia unrelated to cancer treatment.
- Have scalp disorders that preclude the evaluation of alopecia, such as psoriasis
- Has a known hypersensitivity to minoxidil
- Concurrent use of other therapies for alopecia
- Concurrent active anticancer therapies (cytotoxic, targeted, endocrine, immunologic)
- History of chronic sclerotic cutaneous GvHD affecting the scalp
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- Active chronic cutaneous GvHD
- History of orthostatic or symptomatic hypotension, syncope related to hypotension; systolic less than or equal than 100 (for adults) and 90 (for children) at screening.
- Pregnancy.
- Cardiovascular disease that in the opinion of the cardiologist makes the patient unsuitable for therapy
- Blood pressure less than the 5th percentile or less than 90/50 mmHg for children 10 years or older
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors
This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Other purposes of this study include looking at whether participants are able to follow their study drug dosing schedules, and how oral minoxidil affects participants' quality of life.
- Conditions
- Survivors of Childhood Cancer, Alopecia
- Being tested
- Oral Minoxidil, Placebo
- Keywords
- Hair loss, Minoxidil, 23-022
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral MinoxidilDrug
minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day
PlaceboOther
placebo for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Oral Minoxidil | Experimental | Patients receive oral minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months Receives: Drug: Oral Minoxidil |
| Placebo followed by oral Minoxidil | Active comparator | Patient receive placebo for 4 months followed by oral minoxidil for 4 months Receives: Drug: Oral Minoxidil; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements.
Measured: at 4 months
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements.
Measured: at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start10 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Childhood CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alina Markova, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778825
- Sponsor's protocol ID
- 23-022
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05778825
- Acronym / sponsor ID
- 23-022
- Conditions
- Survivors of Childhood Cancer, Alopecia
- Keywords
- Hair loss, Minoxidil, 23-022
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Mar 2023 (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.
This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Other purposes of this study include looking at whether participants are able to follow their study drug dosing schedules, and how oral minoxidil affects participants' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Minoxidil | Experimental | Drug: Oral MinoxidilPatients receive oral minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months |
| Placebo followed by oral Minoxidil | Active comparator | Drug: Oral Minoxidil, Other: PlaceboPatient receive placebo for 4 months followed by oral minoxidil for 4 months |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients must have been diagnosed with cancer before the age of 17.
- They must have completed either systemic or radiation therapy (cytotoxic chemotherapy and external beam radiation therapy) for their cancer at least 1 year prior to study entry.
- They must be between 6-18 years old at the time of enrollment.
- They must have a clinical diagnosis of persistent or late alopecia for >6 months and that is definitely, probably, or possibly related to prior chemotherapy and/or radiation.
Key exclusion criteria (11 listed)
- Had a history of alopecia prior to systemic or radiation therapy for cancer, or has alopecia unrelated to cancer treatment.
- Have scalp disorders that preclude the evaluation of alopecia, such as psoriasis
- Has a known hypersensitivity to minoxidil
- Concurrent use of other therapies for alopecia
- Concurrent active anticancer therapies (cytotoxic, targeted, endocrine, immunologic)
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 Minoxidilminoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day | Drug | Oral Minoxidil, Placebo followed by oral Minoxidil |
| Placeboplacebo for 4 months | Other | Placebo followed by oral Minoxidil |
Primary outcome
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
Time frame: at 4 months
as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements.
change in the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density
Time frame: at 8 months
as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements.
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 20 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Alina Markova, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Minoxidil in people with Survivors of Childhood Cancer and Alopecia, run by Memorial Sloan Kettering Cancer Center 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 4 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 20 Feb 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 the target area (1/3 of the distance midline from glabella to occiput from the front toward the back) hair density (time frame: at 4 months). 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 20 Feb 2026.