Minoxidil for Treating White Hair: A Randomized Controlled Trial (MTWH-RCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Grey Hair
• Intervention / Treatment: Drug: Topical Minoxidil（5%） to the scalp.; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University
    • Zhaoqing, Guangdong, China, 526060
      • The First People's Hospital of Zhaoqing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• Exclusion criteria included various pathological types of gray hair (including, but not limited to, alopecia areata, albinism, radiation-induced gray hair, and vitiligo); any scalp skin diseases (including, but not limited to, androgenetic alopecia, folliculitis, seborrheic dermatitis, psoriasis, tinea capitis, and scalp sebaceous cysts); and any history of medication use or other treatments applied to the scalp within the past year (including, but not limited to, minoxidil, hair transplantation surgery, boric acid lotion, ketoconazole shampoo, and corticosteroid ointments). Patients with severe systemic diseases, immune diseases, endocrine disorders, or neurological diseases were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5%minoxidil group; Participants will apply high concentration Minoxidil (e.g., 5% Minoxidil solution) to the scalp twice daily for 12 months. The main purpose of the treatment is to evaluate the efficacy of high-concentration Minoxidil for treating non-pathological graying and to monitor its safety and tolerability.	Drug: Topical 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.
Placebo Comparator: Placebo Group; This group will receive a placebo solution (similar in appearance and odor to Minoxidil but without the active ingredient), applied to the scalp twice daily for 12months. This placebo group will serve as a control for comparing the effects of Minoxidil on non-pathological graying of hair.	Drug: Placebo; The patient will apply placebo to the scalp twice daily, with 7 sprays (approximately 1 mL) per application, for a duration of 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the appearance gray hair grade	we 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.	From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction 2 level in the appearance gray hair grade	We 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.	From enrollment to the end of treatment at 12 months
White hair percent change from baseline	We 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	From enrollment to the end of treatment at 12 months
Grayscale change	During 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.	From enrollment to the end of treatment at 12 months
Amount of repigment white hair	During 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.	From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Actual): February 15, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: white hair
• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: Minoxidil treats white hair

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No