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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China | ||
| The First People's Hospital of Zhaoqing |
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| 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. |
|
| 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 |
| Zhaoqing |
| Guangdong |
| 526060 |
| China |