Clinical trial NCT06218394: Comparison of Microneedling vs. Autologous Concentrated Growth Factor for the Treatment of Female Androgenetic Alopecia
Official title: Comparison of Microneedling vs. Autologous Concentrated Growth Factor for the Treatment of Female Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Microneedling and autologous concentrated growth factor (CGF) have established their potential effect in inducing hair regrowth. No study has compared the effect of microneedling and CGF in the treatment of female androgenetic alopecia (AGA).

Detailed description: Microneedling is a minimally invasive technique consisting of sterile microneedles for repetitive cutaneous puncturing that increase hair regrowth by growth factor release. Concentrated growth factor (CGF) is a form of platelet concentrate (PC) and concentrates higher levels of growth factors because of its varying programmed centrifugation process. Previous studies have showed that CGF injection in hairless scalp could enhance the hair density and optimize the hairless appearance in AGA patients. Both microneedling and CGF have established their potential effect in inducing hair regrowth. No study has compared the effect of microneedling and CGF in the treatment of female androgenetic alopecia.

Eligibility criteria: Inclusion Criteria:

1. age between 18 and 65 years;；
2. clinical diagnosis of female pattern hair loss；
3. no previous laser treatments for AGA in the past six months before enrollment； 4) willingness to provide pictures and follow-up studies.

Exclusion Criteria:

1. if presented with severe diseases of internal organs, eyes, or skin;
2. inflammation, infection, or unhealed wounds on the skin around the site of treatment on the head;
3. systematic treatment with corticosteroids or other immunosuppressants and immunomodulators in the past 3 months.

Primary outcomes:
measure: TAHC
timeFrame: week 24
Secondary outcomes:
measure: HGQA
timeFrame: week 8, week 12, week 16, week 24, week 36
measure: TAHC
timeFrame: week 8, week 12, week 20, week 36
measure: TAHW
timeFrame: week 8, week 12, week 16, week 24, week 36
measure: IGA
timeFrame: week 8, week 12, week 16, week 24, week 36
measure: Grade of Ludwig and Norwood-Hamilton Classification
timeFrame: week 12, week 24, week 36
measure: SSA
timeFrame: week 8, week 12, week 16, week 24, week 36
Other outcomes:
measure: Incidents of adverse events
timeFrame: through study completion, an average of 36 weeks
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xianjie Wu
role: PRINCIPAL_INVESTIGATOR
References: