Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
18 participants
INTERVENTIONAL
2025-04-30
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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exosomes
Subjects will receive 5E8 \~5E9 particles/cm² of exosome therapy in the study area during the dose escalation phase.
exosomes
Each subject will receive 3 injections with an interval of one month.
saline
The control site will receive the same volume of saline as the exosomes administered in the study site.
saline
Each subject will receive 3 injections with an interval of one month.
Interventions
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exosomes
Each subject will receive 3 injections with an interval of one month.
saline
Each subject will receive 3 injections with an interval of one month.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Guangzhou Bio-gene Technology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BG-CT-24-007
Identifier Type: -
Identifier Source: org_study_id
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