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

NCT06218394 | Unknown

• 1 other identifier: 20230984
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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).

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• TAHC

  Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .

  week 24

Secondary Outcomes (6)

• HGQA

  week 8, week 12, week 16, week 24, week 36

• TAHC

  week 8, week 12, week 20, week 36

• TAHW

  week 8, week 12, week 16, week 24, week 36

• IGA

  week 8, week 12, week 16, week 24, week 36

• Grade of Ludwig and Norwood-Hamilton Classification

  week 12, week 24, week 36

Other Outcomes (1)

• Incidents of adverse events

  through study completion, an average of 36 weeks

Study Arms (3)

microneedling

EXPERIMENTAL

Procedure: microneedling

autologous concentrated growth factor

EXPERIMENTAL

Procedure: Autologous Concentrated Growth Factor

5% minoxidil

ACTIVE COMPARATOR

Drug: 5% minoxidil

Interventions

microneedling 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.

microneedling

Autologous Concentrated Growth Factor 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.

autologous concentrated growth factor

5% minoxidil DRUG

topical 5% minoxidil, 1 ml, once daily

5% minoxidil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Percutaneous Collagen Induction; Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Xianjie Wu

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru Dai

CONTACT

+8615982215914; dairu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 23, 2024
• Study Start: December 14, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)