Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06218394
Other study ID # 20230984
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 14, 2023
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Ru Dai
Phone +8615982215914
Email dairu@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.
Drug:
5% minoxidil
topical 5% minoxidil, 1 ml, once daily

Locations

Country Name City State
China Second Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Incidents of adverse events Safety assessment through study completion, an average of 36 weeks
Primary TAHC Use the trichoscopy to assess the changing number of non-vellus hairs in the target area . week 24
Secondary HGQA Hair growth questionnaire assessment week 8, week 12, week 16, week 24, week 36
Secondary 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
Secondary 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
Secondary 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
Secondary Grade of Ludwig and Norwood-Hamilton Classification The Grade of Ludwig and Norwood-Hamilton Classification week 12, week 24, week 36
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT02591355 - Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment N/A
Withdrawn NCT03852992 - Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Phase 2
Recruiting NCT06239207 - Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia Phase 2
Completed NCT04945226 - A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 Phase 1/Phase 2
Completed NCT01548066 - The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss Phase 2
Completed NCT01437163 - Treatment of Androgenetic Alopecia in Males and Females N/A
Completed NCT01226459 - Clinical Trial in Females for Female Pattern Hair Loss Phase 3
Recruiting NCT06118866 - A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia Phase 2
Completed NCT06149221 - Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss N/A
Withdrawn NCT04882969 - Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia N/A
Completed NCT01231607 - Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Phase 3
Completed NCT04446429 - Anti-Androgen Treatment for COVID-19 N/A
Completed NCT02729415 - Point-of-Care Adipose-derived Cells for Hair Growth N/A
Completed NCT02279823 - A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia Phase 2
Not yet recruiting NCT01227031 - Pharmacogenomic Study of Androgenetic Alopecia N/A
Completed NCT00981461 - Treatment of Androgenetic Alopecia in Females, 9 Beam N/A
Completed NCT01451021 - A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Phase 2
Completed NCT00151515 - A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Phase 3
Completed NCT03694067 - Androgenetic Alopecia and the JAK-STAT Pathway
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A