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

NCT ID: NCT06218394

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-14
• Study Completion Date: 2024-12-31

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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

microneedling

Group Type: EXPERIMENTAL

microneedling

Intervention Type: PROCEDURE

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.

autologous concentrated growth factor

Group Type: EXPERIMENTAL

Autologous Concentrated Growth Factor

Intervention Type: PROCEDURE

1. 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.

2. 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.

5% minoxidil

Group Type: ACTIVE_COMPARATOR

5% minoxidil

Intervention Type: DRUG

topical 5% minoxidil, 1 ml, once daily

Interventions

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.

Intervention Type: PROCEDURE

Autologous Concentrated Growth Factor

1. 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.

2. 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.

Intervention Type: PROCEDURE

5% minoxidil

topical 5% minoxidil, 1 ml, once daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xianjie Wu

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ru Dai

Role: CONTACT

dairu@zju.edu.cn

+8615982215914

Facility Contacts

Ru Dai, Ph.D

Role: primary

dairu@zju.edu.cn

86 15982215914

Other Identifiers

20230984

Identifier Type: -

Identifier Source: org_study_id