Clinical trial NCT06813963: Minoxidil for Treating White Hair: a Randomized Controlled Trial
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Minoxidil in the Repigmentation of White Hair in Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Grey Hair
Keywords: white hair
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in the appearance gray hair grade
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Reduction 2 level in the appearance gray hair grade
timeFrame: From enrollment to the end of treatment at 12 months
measure: White hair percent change from baseline
timeFrame: From enrollment to the end of treatment at 12 months
measure: Grayscale change
timeFrame: From enrollment to the end of treatment at 12 months
measure: Amount of repigment white hair
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
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