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

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).

Study Overview

• Status: Recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Procedure: microneedling; Procedure: Autologous Concentrated Growth Factor; Drug: 5% minoxidil

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 Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ru Dai; Phone Number: +8615982215914; Email: dairu@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Ru Dai, Ph.D; Phone Number: 86 15982215914; Email: dairu@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5% minoxidil	Drug: 5% minoxidil; topical 5% minoxidil, 1 ml, once daily
Experimental: microneedling	Procedure: microneedling; The microneedling technique (Electric microneedle, F6, China Bohui Meicui Bioengineering Technology Guangzhou Co., LTD.) performed in the targeted areas using a sterile micro needles stamp. In this study, the needle length was adjusted to 0.7~1 mm according to the grade of hair loss and the degree of tolerance of the patient. Before microneedling treatment, the scalp was disinfected with 75% alcohol, and then 1 ml of nutritional dressing for the scalp was applied externally, and the microneedle pen was gently touched to the scalp vertically for pricking. Patients are instructed to refrain from shampooing, warm baths, and strenuous exercise for 8 hours after treatment. Each patient was treated by microneedling once every 2 weeks for a total of 12 treatments.
Experimental: autologous concentrated growth factor	Procedure: Autologous Concentrated Growth Factor; 27~36ml of autologous venous blood is collected in a sterile Vacuette tube without anticoagulant solution, and centrifuged by Medifuge variable speed centrifuge (Silfradent company, Italy) for about 13min (accelerated for 30s; 2700 r/min, 2 min; 2400 r/min, 4min; 2700r/min, 4min; 3300r/min, 3 min; decelerated for 36s to stop). The lowest layer retains 2.5ml of CGF per 9ml of venous blood.; The scalp is cleaned, disinfected and anesthetized, CGF is extracted with a 2.5ml syringe, and the disposable sterile needle roller handle is slowly rolled in the hair loss area, and the CGF is applied to the corresponding scalp part for introduction treatment while rolling, and the force is uniform and stable, repeating back and forth several times, to the extent that the patient can tolerate and the skin in the treatment area is slightly red. The operation time is about 15~20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAHC	Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HGQA	Hair growth questionnaire assessment	week 8, week 12, week 16, week 24, week 36
TAHC	Use the trichoscopy to assess the changing number of non-vellus hairs in the target area	week 8, week 12, week 20, week 36
TAHW	Use the trichoscopy to assess the changing diameter of non-vellus hairs in the target area	week 8, week 12, week 16, week 24, week 36
IGA	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.	week 8, week 12, week 16, week 24, week 36
SSA	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.	week 8, week 12, week 16, week 24, week 36
Grade of Ludwig and Norwood-Hamilton Classification	The Grade of Ludwig and Norwood-Hamilton Classification	week 12, week 24, week 36

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidents of adverse events	Safety assessment	through study completion, an average of 36 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Xianjie Wu, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 21, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Mitosis Modulators; Mitogens; Minoxidil
• Other Study ID Numbers: 20230984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study are not publicly available due to the privacy of research participants but are available from the sponsor upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No