Minoxidil for Treating White Hair: A Randomized Controlled Trial

NCT06813963 | Completed Phase 4

• 1 other identifier: Minoxidil treats white hair
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 2

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.

Conditions

Grey Hair

Keywords

white hair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Reduction 2 level in the appearance gray hair grade

  From enrollment to the end of treatment at 12 months

• White hair percent change from baseline

  From enrollment to the end of treatment at 12 months

• Grayscale change

  From enrollment to the end of treatment at 12 months

• Amount of repigment white hair

  From enrollment to the end of treatment at 12 months

Study Arms (2)

5%minoxidil group

EXPERIMENTAL

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.

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Topical Minoxidil（5%） to the scalp. DRUG

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.

5%minoxidil group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (2)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The First People's Hospital of Zhaoqing

Zhaoqing, Guangdong, 526060, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student in Plastic Surgery

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: February 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (2)