Grey HairPhase 4MTWH-RCTNCT06813963
Minoxidil for Treating White Hair: A Randomized Controlled Trial
A Phase 4 study testing Topical Minoxidil（5%） to the scalp. in people with Grey Hair, run by Southern Medical University, China at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Grey Hair
- What is being tested?
- Topical Minoxidil（5%） to the scalp.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 2 sitesChina
- Study dates
- 15 Feb 2025to 15 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
The First People's Hospital of Zhaoqing
Zhaoqing, Guangdong, 526060
About this study
Official title: 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:
Read more
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
- Being tested
- Topical Minoxidil（5%） to the scalp., Placebo
- Keywords
- white hair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
The patient will apply placebo to the scalp twice daily, with 7 sprays (approximately 1 mL) per application, for a duration of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start15 Feb 2025
- Primary completion15 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grey HairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wangzehao He, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813963
- Sponsor's protocol ID
- Minoxidil treats white hair
- Acronym
- MTWH-RCT
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Minoxidil in the Repigmentation of White Hair in Adults
- ClinicalTrials.gov ID
- NCT06813963
- Acronym / sponsor ID
- MTWH-RCT / Minoxidil treats white hair
- Conditions
- Grey Hair
- Keywords
- white hair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5%minoxidil group | Experimental | Drug: Topical Minoxidil（5%） to the scalp.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. |
| Placebo Group | Placebo comparator | Drug: PlaceboThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | 5%minoxidil group |
| PlaceboThe patient will apply placebo to the scalp twice daily, with 7 sprays (approximately 1 mL) per application, for a duration of 12 months. | Drug | Placebo Group |
Primary outcome
Reduction in the appearance gray hair grade
Time frame: From enrollment to the end of treatment at 12 months
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.
4 secondary outcomes
Reduction 2 level in the appearance gray hair grade
Time frame: From enrollment to the end of treatment at 12 months
White hair percent change from baseline
Time frame: From enrollment to the end of treatment at 12 months
Grayscale change
Time frame: From enrollment to the end of treatment at 12 months
Amount of repigment white hair
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical Minoxidil（5%） to the scalp. in people with Grey Hair, run by Southern Medical University, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the appearance gray hair grade (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.