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

Southern Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Grey Hair

Treatments: Drug: Topical Minoxidil（5%） to the scalp.; Drug: Placebo; Drug: 2%minoxidil group

Study type: Interventional

Funder types: Other

Identifiers

NCT06813963

Minoxidil treats white hair

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups, including a placebo group

5%minoxidil group

Experimental group

Description:

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.

Treatment:

Drug: Topical Minoxidil（5%） to the scalp.

2% Minoxidil Group

Experimental group

Description:

This group will receive 2% Minoxidil solution, applied to the white hair areas of the scalp twice daily for 12 months. This intervention aims to evaluate the efficacy and safety of low concentration Minoxidil in treating non-pathological graying of hair.

Treatment:

Drug: 2%minoxidil group

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo