Comparison of Microneedling vs. Autologous Concentrated Growth Factor for the Treatment of Female Androgenetic Alopecia

Not Applicable

Recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Drug: 5% minoxidil; Procedure: microneedling; Procedure: Autologous Concentrated Growth Factor

• Registration Number: NCT06218394
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-14
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-21
• Last Update Submitted: 2024-01-21
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% minoxidil	5% minoxidil	-
microneedling	microneedling	-
autologous concentrated growth factor	Autologous Concentrated Growth Factor	-

Primary Outcome Measures

Name	Time	Method
TAHC	week 24	Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .

Secondary Outcome Measures

Name	Time	Method
IGA	week 8, week 12, week 16, week 24, week 36	Investigator's Global Assessment. IGA was evaluated using a 7-point scale as follows: -3= obvious reduction of hair; -2= moderate reduction of hair; -1= mild reduction of hair; 0= change; 1= mild growth of hair; 2= moderate growth of hair; 3= obvious growth of hair.
Grade of Ludwig and Norwood-Hamilton Classification	week 12, week 24, week 36	The Grade of Ludwig and Norwood-Hamilton Classification
TAHC	week 8, week 12, week 20, week 36	Use the trichoscopy to assess the changing number of non-vellus hairs in the target area
HGQA	week 8, week 12, week 16, week 24, week 36	Hair growth questionnaire assessment
TAHW	week 8, week 12, week 16, week 24, week 36	Use the trichoscopy to assess the changing diameter of non-vellus hairs in the target area
SSA	week 8, week 12, week 16, week 24, week 36	Subject self-assessment. SSA was evaluated using a 7-point scale as follows: -3= obvious reduction of hair; -2= moderate reduction of hair; -1= mild reduction of hair; 0= change; 1= mild growth of hair; 2= moderate growth of hair; 3= obvious growth of hair.

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China