A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Alina Markova, MD
- Phone Number: 646-608-2342
- Email: markovaa@mskcc.org
Study Contact Backup
- Name: Danielle Friedman, MD
- Phone Number: 212-639-7376
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Oral Minoxidil
Patients receive oral minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months
|
minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day
|
|
Active Comparator: Placebo followed by oral Minoxidil
Patient receive placebo for 4 months followed by oral minoxidil for 4 months
|
minoxidil at a dose of 0.01 (<40kg) and 0.02 (≥40kg) mg/kg/day
placebo for 4 months
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
at 8 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Alina Markova, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 23-022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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