androgenetic alopecia
Conditions
Interventions
the treated side:Laser treatment for 24 weeks
Control side:Leave untreated for 3 months and start treatment for 3 months
Sponsors
Peking University People’s Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1)age 18-50 years male; 2)diagnosis of AGA class IIIv–VI, according to the Hamilton-Norwood scale; 3)keep the same hair style, hair color and hair length at each follow-up visit; 4)understand the purpose of the trial, willing to sign informed consents and have the ability to follow the study protocol including its follow-up and evaluation;
Exclusion criteria
Exclusion criteria: 1)The use of oral dutasteride within 18 months prior to the start of the trial or the use of oral finasteride within 12 months prior to the start of the trial ; 2)The use of platelet-rich plasma treatment within 6months prior to the start of the trial; 3)The use of topical or systemic drugs affecting hair growth within 6 months prior to the start of the trial(such as minoxidil); 4)Laser treatment or scalp light within 6 monthsprior to the start of the trial; 5)The use of topical drugs on bald scalp that may interfere the evaluation of treatment efficacy for 2 or more consecutive weeks within 3 months prior to the start of the trial (including corticosteroids, estrogens, etc.); 6)Receiving systemic retinoids within 3 months prior to the start of the trial; 7)Receiving androgen replacement treatment, immunosuppressant or other drugs that may interfere with the evaluation of efficacy within 3 months prior to the start of the trial; 8)Treatment with surgical procedure within 3 months, or with surgical procedure plans during the study; 9)Participating other drug or medical devices clinical trial within 3 months prior to the start of the trial; 10)The use of OTC drugs, supplements, other medical shampoos or solutions containing ketoconazole and similar ingredients that may interfere with the assessments within 1 month prior to the start of the trial; 11)A history of malignant tumor within 5 years prior to the start of the trial; 12)Receiving chemotherapy or cytotoxic agents treatment within 1 years prior to the start of the trial; 13)A history of drug abuse within 1 years prior to the start of the trial or a history of drug or alcohol addicts within 3 months prior to the start of the trial ; 14)Positive results for any one or more of syphilis spirochetes or human immunodeficiency virus (HIV) antibodies or hepatitis B surface antigen or hepatitis C virus antibodies; 15)Chronic illness or systemic disorder (e.g.hypertension, diabetes, bleeding disorders, severe infectious diseases, immune system diseases, malignant tumor, hepatitis, or thyroid disease); 16)A history of scalp surgery(e.g.hair transplantation, scalp reduction surgery) or using hair powder, hair fibers during study or using wig cover and hair adhesive for long time; 17)Suffering from diseases that may affect hair growth such as connective tissue disease, inflammatory bowel disease, moderate to severe anemia, significant weight loss in the short term.etc; 18)Suffering from scalp dermatosis that may interfere with the evaluation of assessment, scalp injuries or other scalp dermatosis treated by topical drugs(e.g.fungal or bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy;); 19)Prepare for pregnancy during the study; 20)A history of scar diathesis(containing hypertrophic scar and keloid); 21)A history of mental disorders; 22)Judged inappropriate to participate in the study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the treated side difference in the change in non-vellus hair density from baseline to week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in non hair count (TAHC) in the target area compared to baseline at 24 weeks of treatment on the treatment and control sides;Hair growth in the target area compared to baseline at 12 and 24 weeks of treatment on the treatment and control sides;Changes in non vellus hair diameter (TAHW) in the target area of the treatment side and control side compared to baseline at 12 and 24 weeks of treatment;Changes in the final hair/vellus hair ratio in the target area compared to baseline at 12 and 24 weeks of treatment on the treatment and control sides;Changes in the growth/rest hair ratio in the target area compared to baseline at 12 and 24 weeks of treatment on the treatment and control sides;Changes in Hamilton Norwood grading at 12 and 24 weeks of treatment on the treatment and control sides; | — |
Countries
CHINA
Contacts
Public ContactZHOU CHENG
Peking University People’s Hospital
Outcome results
None listed