Loss of hair
Conditions
Interventions
Experimental group:Laser hair growth therapy machine treatment
Laser hair growth therapy machine treatment:Minoxidil treatment
Sponsors
Fudan University Affiliated Huashan Hospital
Eligibility
Sex/Gender
All
Age
21 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Subjects aged 21-60 years (including threshold), regardless of gender; (2) Fitzpatrick skin types are I-IV and there is a need to improve the appearance of scalp hair; (3) Male subjects diagnosed clinically with androgenic alopecia, who meet Hamilton Norwood Scale II Vertex, III Vertex, IV types, or female or male subjects who meet Sinclair grading criteria of grade II or III; (4) Agree to maintain the same hairstyle, hair color, and hair length during the study period, without using special hair care products or hair care; (5) Voluntarily follow the requirements of the trial protocol to participate in this clinical trial and sign the informed consent form of the subjects.
Exclusion criteria
Exclusion criteria: (1) Known to suffer from hair loss diseases other than androgenetic alopecia (such as alopecia areata, alopecia areata, syphilitic alopecia, scar alopecia, malnutrition induced alopecia, etc.); (2) Subjects who have used finasteride (or any other 5-alpha-reductase inhibitor), spironolactone, minoxidil (local or systemic) in the 6 months prior to the screening period; (3) Screening for individuals who have received chemotherapy, cytotoxic drugs, local injection of autologous platelet rich plasma (PRP), microneedling, traditional Chinese medicine external treatment, scalp radiotherapy and/or laser/surgical treatment, or scalp ornamentation (SMP) treatment in the observation area within the previous 12 months; (4) Individuals who have undergone hair transplantation before screening or require long-term use of wig headgear and hair adhesives during experimental treatment; (5) Screening for cosmetics and health products with hair growth effects used within the previous 3 months; (6) Participants who have lost more than 5kg/month in weight loss within the first 3 months of screening, or who have undergone general anesthesia surgery, or who have developed high fever (above 38.5 ?). (7) Patients who are allergic to minoxidil, or are currently in the active stage of skin allergies, or have skin cancer or precancerous lesions; (8) Based on the judgment of the researchers, it is believed that the subjects have a history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, blood, endocrine, metabolic, immune, psychiatric, and neurological diseases that may affect the research objectives and evaluation; (9) Patients with acute or progressive skin diseases (including but not limited to folliculitis, contact dermatitis, atopic dermatitis, psoriasis, vitiligo, eczema, etc.), active skin infections, herpes, or open wounds in the intended treatment area; (10) Previous use of minoxidil or laser therapy for hair loss has been ineffective; (11) Diagnosed with hypotension (blood pressure<90 mmHg/60 mmHg) within one month prior to screening; (12) Pregnant and lactating women, or those planning to become pregnant during the study period; (13) Individuals who have participated in clinical trials of other intervention devices or within 5 half lives of their last medication in a drug clinical trial within one month prior to the start of this trial; (14) Researchers believe that other individuals are not suitable to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in non laser count (TAHC) within the baseline target area; | — |
Secondary
| Measure | Time frame |
|---|---|
| Final hair density, vellus hair density, final hair/vellus hair ratio, hair follicle density, hair stem diameter, etc;;Assessment of hair loss grade;7-level rating system evaluation;Pain score;Subject satisfaction evaluation;Evaluation of instrument operation performance; | — |
Countries
Chnia
Contacts
Public ContactWu Wenyu
Fudan University Affiliated Huashan Hospital
Outcome results
None listed