Status:
NOT_YET_RECRUITING
Exosomes for Hairloss Treatment
Lead Sponsor:
Guangzhou Bio-gene Technology Co., Ltd
Conditions:
Hair Loss
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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. Exosome...
Eligibility Criteria
Inclusion
- Subjects are able to read documents and can sign informed consent.
- 18\~75 years old (including the threshold), gender is not limited.
- 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
- People with patchy or diffuse baldness, syphilitic alopecia, scarring alopecia, malnutrition, chemotherapy/radiotherapy-induced hair loss.
- Those with a combination of diseases that have an impact on hair growth.
- 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).
- Have received scalp radiation and/or laser or surgical therapy within 3 months prior to screening.
- Participated or are participating in a interventional clinical trial within 3 months.
- Persons with a history of hereditary alopecia areata.
- Women who are pregnant or breastfeeding, or male/female subjects whose own/partner's pregnancy is planned within 6 months.
- Have undergone hair transplantation in the previous 24 months.
- Individuals testing positive for active infectious diseases or carriers of communicable pathogens.
- Those with keloid, keloid-prone or hyperplastic scarring.
- Those who, in the opinion of the investigator, are otherwise unfit to participate in this clinical study.
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06932393
Start Date
April 30 2025
End Date
April 30 2028
Last Update
April 17 2025
Active Locations (1)
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1
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen, Guangdong, China, 518067