A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors

Alopecia Clinical Trial

Official title:

A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778825
• Other study ID #: 23-022
• Status: Recruiting
• Phase: Phase 2
• Start date: March 10, 2023
• Est. completion date: March 2026

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Alina Markova, MD
• Phone: 646-608-2342
• Email: markovaa[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Survivors of Childhood Cancer

Intervention

Drug:
• Oral Minoxidil
minoxidil at a dose of 0.01 (<40kg) and 0.02 (=40kg) mg/kg/day

Other:
• Placebo
placebo for 4 months

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 4 months
Primary	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.	at 8 months

External Links

•   Memorial Sloan Kettering Cancer Center