Hair Loss
Conditions
Keywords
Hair Loss, Exosomes
Brief summary
Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human mesenchymal stem cells and purified using specific processing. This study is a randomized, double-blind, dose-escalation clinical trial designed to evaluate the efficacy and safety of exosomes therapy for alopecia.
Interventions
BIOLOGICALexosomes
Each subject will receive 3 injections with an interval of one month.
OTHERsaline
Each subject will receive 3 injections with an interval of one month.
Sponsors
Guangzhou Bio-gene Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects are able to read documents and can sign informed consent. 2. 18\~75 years old (including the threshold), gender is not limited. 3. The subject's "hair loss grade" meets the following criteria: 1\) BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or special type (V1 to V3, or F1 to F3); 2) For female: Ludwig Grade I to II. Or for male: Hamilton-Norwood Grade III to IV; 3) Hair density by phototrichogram: ≤ 190 hair/cm² ; 4. Hair dryness ≥ 5%; 5. Until withdrawal/completion of the study, subjects agree not to undergo any topical treatment for hair loss and agree to use a neutral shampoo.
Exclusion criteria
1. People with patchy or diffuse baldness, syphilitic alopecia, scarring alopecia, malnutrition, chemotherapy/radiotherapy-induced hair loss. 2. Those with a combination of diseases that have an impact on hair growth. 3. Use of medications, medicated shampoos, or hair care products that may interfere with efficacy evaluation within 3 months prior to screening (oral administration of therapeutic agents for androgenetic alopecia must be discontinued for at least 6 months). 4. Have received scalp radiation and/or laser or surgical therapy within 3 months prior to screening. 5. Participated or are participating in a interventional clinical trial within 3 months. 6. Persons with a history of hereditary alopecia areata. 7. Women who are pregnant or breastfeeding, or male/female subjects whose own/partner's pregnancy is planned within 6 months. 8. Have undergone hair transplantation in the previous 24 months. 9. Individuals testing positive for active infectious diseases or carriers of communicable pathogens. 10. Those with keloid, keloid-prone or hyperplastic scarring. 11. Those who, in the opinion of the investigator, are otherwise unfit to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of localized hair density | 3rd month after 3 treatments | Quantify hair counts within designated 1.5 cm × 1.5 cm fixed areas in both the study area and control area, and compare the localized hair density (hair/cm²) between the two areas. |
| Safety Assessment | From the initial treatment administration to the subject withdrawal from the study. | Incidence of treatment emergent adverse events (TEAEs) |
| Comparison of overall hair density | 3rd month after 3 treatments | Evaluate and score overall hair density in both the study area and control area using an 8-level assessment scale, followed by a comparative analysis of the two areas. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of hair density | 3rd and 6st month after 3 treatments | Change in hair density of study area with the baseline. |
Countries
China
Outcome results
None listed