Female androgenetic alopecia
Conditions
Interventions
Single - drug group:Take Huoxue Shengfa Capsules orally
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1Those who meet the Western medical diagnostic criteria for female androgenetic alopecia; 2With Savin grade I1 - II2; 3Those who meet the syndrome diagnostic criteria of blood stasis blocking the collaterals type of androgenetic alopecia in traditional Chinese medicine; 4Aged between 18 and 50 years old; 5Willing to use the same shampoo as much as possible during the research period and keep the same hairstyle hair length and hair color; 6Willing to follow the requirements of the research protocol including getting a micro - dot tattoo on the scalp of the target area (1 cm × 1 cm on the top of the head); 7Willing and able to complete the filling of diary cards during the research period; 8Agree to use effective contraception during the research period; 9Understand the experimental procedures and content and voluntarily sign the informed consent form
Exclusion criteria
Exclusion criteria: 1Hair loss caused by other reasons such as congenital alopecia cicatricial alopecia lupus alopecia syphilitic alopecia alopecia areata and trichotillomania. 2Subjects with other active skin diseases scalp diseases or active scalp trauma that in the opinion of the investigator may affect the evaluation of the efficacy or safety of the study. Subjects who have shaved their heads cannot be enrolled in the study until their hair has regrown and the investigator deems it will not affect the evaluation results. 3Have used relevant drugs and products within 2 weeks before enrollment (see the study protocol for details). 4Diseases that in the judgment of the investigator may compromise the safety of the subject or interfere with the interpretation of the study results (see the study protocol for details). 5Abnormal and clinically significant examination results during the screening period and which in the judgment of the investigator affect the safety assessment of the subject. 6Pregnant and lactating women. 7History of hair transplantation. 8Currently participating in other interventional clinical studies. 9Subjects known to be allergic to the test drug or its components or subjects allergic to any component of the tattoo ink. 10Patients who in the judgment of the investigator are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the count of non-vellus hairs(TAHC) in the target area (1 cm × 1 cm at the vertex)) compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Savin grade compared to the baseline;Investigator Photographic Assessment Questionnaire [IPAQ] Scores;Change in the ratio of terminal hairs to vellus hairs in the target area compared to the baseline;Change in the count of non-vellus hairs(TAHC) in the target area (1 cm × 1 cm at the vertex)) compared to the baseline; | — |
Countries
China
Contacts
Public ContactCao Yi
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Outcome results
None listed