androgenic alopecia, AGA
Conditions
Interventions
1:Single cream+ Red light
Sponsors
Shanghai Dermatology Hospital
Eligibility
Sex/Gender
Male
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male aged 20-50 years; 2. A history of losing hair more than 6 month; 3. Diagnosed as androgenetic alopecia according to the Guideline for Diagnosis and Treatment of Androgenetic Alopecia, classified as type III-V (including types IV anterior and V anterior) using the Norwoode-Hamilton classification; 4. Had not used topical or systemic medications affecting hair growth, such as finasteride, cyclosporine, or minoxidil, within the past 1 month; 5. Have not received hair transplantation or scalp reduction; 6. Maintain the same hair color and style for the study duration; 7. In good health condition: no clinically significant abnormal results in general physical examination(including blood pressure, heart rate, respiratory rate, electrocardiogram) as well as laboratory examination (including blood routine tests, urine routine tests, liver function, renal function, blood glucose; 8. Be Unwilling or unsuitable to take medicine, or had limited response to various treatments, being remind of other alternative therapy but still choose voluntary participation; 9. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: The subject should be excluded once meeting anyone of the criteria: 1. A history of losing hair less than 6 month; 2. Any other condition/disease of the scalp/hair that might affect diagnose or efficacy evaluation; 3. Had not used topical or systemic medications affecting hair growth, such as finasteride, cyclosporine, or minoxidil, within the past 1 month; 4. Used to receive hair transplantation or scalp reduction; 5. Change the hair color or style for the study duration; 6. Have serious internal medicine diseases; 7. Known porphyria patient, or allergic to ALA as well as its analogues in chemical structure, or allergic to the light; 8. In addition to the above, unsuitable to this clinical trial judged by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changing from baseline in hair count within a 2.54-cm diameter circle at the vertex at 6th treatment (hair growth); | — |
Secondary
| Measure | Time frame |
|---|---|
| hair growth (change from baseline in hair count within a 2.54-cm diameter circle [6th treatment] and 1.13-cm diameter circle [6th and 12th treatments] at the vertex and the frontal);hair density, hair width, terminal hair (hair width =60µm) count, anagen follicular count, telogen(including catagen) follicular count, anagen vs. telogen ratio (A/T) (change from baseline in hair count within a 2.54-cm and 1.13-cm diameter circle [6th and 12th treatments] at the vertex and the frontal);panel (3 dermatologists) global photographic assessment of improvement at the vertex and frontal views (from baseline to the end of 6th treatment);investigator global photographic assessment of improvement at the vertex and frontal views (from baseline to the end of 3th treatment, 6th treatment, 6 weeks after 6th treatment and 12 weeks after 6th treatment ) and the change in androgenetic alopecia stage according to Norwoode-Hamilton scale (screening, end;Subjects’ assessments of the change in hair growth (4-questioned inquiry) and satisfaction with hair appearance (3-questioned inquiry) at the end of 6th treatment and 12 weeks after the 6th treatment;terminal hair (hair width =60µm) follicular count, vellus hair follicular count, terminal/vellus ratio, anagen follicular count, telogen(including catagen) follicular count, anagen vs. telogen ratio (A/T) in the specimens (before the first treatment, after 6th treatment, 12 weeks after 6th treatment); | — |
Countries
China
Contacts
Public ContactXiuli Wang
Shanghai Dermatology Hospital
Outcome results
None listed