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Minoxidil for Treating White Hair: A Randomized Controlled Trial

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Minoxidil in the Repigmentation of White Hair in Adults

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06813963
Acronym
MTWH-RCT
Enrollment
141
Registered
2025-02-07
Start date
2025-02-15
Completion date
2026-03-15
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grey Hair

Keywords

white hair

Brief summary

The goal of this clinical trial is to evaluate whether topical Minoxidil can restore hair pigmentation in individuals with non-pathological graying hair. The study population includes male and female participants aged \[18to65\] who have non-pathological graying of hair, meaning their graying is not due to any underlying medical conditions. The main questions it aims to answer are: Does topical Minoxidil improve hair pigmentation in individuals with non-pathological graying hair? What medical problems do participants have when topical use minoxidil? Researchers will compare participants receiving topical Minoxidil to those receiving a placebo to determine whether Minoxidil has a significant effect on restoring hair pigmentation. Participants will: Topical use minoxidil or a placebo twice a day for 12 months Visit the clinic once every months for checkups and tests Report any adverse effects or changes in hair characteristics throughout the study.

Interventions

DRUGTopical Minoxidil(5%) to the scalp.

The patient will apply 5% Minoxidil topical solution to the scalp twice daily, with 7 sprays (approximately 1 mL) per application, for a duration of 12 months.

DRUGPlacebo

The patient will apply placebo to the scalp twice daily, with 7 sprays (approximately 1 mL) per application, for a duration of 12 months.

Sponsors

Southern Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* The patients included in the study were those with a visible gray hair grading score of 2 or higher at screening and baseline visits, with depigmented hair shafts observable under dermoscopy.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Reduction in the appearance gray hair gradeFrom enrollment to the end of treatment at 12 monthswe divided gray hair appearance into 11 progressive levels of severity, ranging from grade 0: fully pigmented(%), to grade 10:completely unpigmented(100%).Two trained physicians (blinded to the trial group assignments) used a gray hair appearance color scale to rate patients' gray hair appearance to determine whether the primary outcome definition was met.

Secondary

MeasureTime frameDescription
Reduction 2 level in the appearance gray hair gradeFrom enrollment to the end of treatment at 12 monthsWe divided gray hair appearance into 11 progressive levels of severity, ranging from grade 0: fully pigmented, to grade 10: completely unpigmented.Two trained physicians (blinded to the trial group assignments) used a gray hair appearance color scale to rate patients' gray hair appearance to determine whether the primary outcome definition was met.
White hair percent change from baselineFrom enrollment to the end of treatment at 12 monthsWe used tattoo to mark the patient's scalp and temporal areas, and observed the number of gray and black hairs at the marked locations using a dermatoscope. During each follow-up, we reassessed the gray-to-black hair ratio and any changes in hair pigmentation at the marked areas
Grayscale changeFrom enrollment to the end of treatment at 12 monthsDuring each follow-up, we photographed the patient's appearance and used ImageJ software to measure the grayscale value of the hair in the patient's appearance photos.
Amount of repigment white hairFrom enrollment to the end of treatment at 12 monthsDuring each follow-up, we photographed the patient's appearance and used ImageJ software to measure the grayscale value of the hair in the patient's appearance photos.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026