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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microneedling | Experimental |
| |
| autologous concentrated growth factor | Experimental |
| |
| 5% minoxidil | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TAHC | Use the trichoscopy to assess the changing number of non-vellus hairs in the target area . | week 24 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidents of adverse events | Safety assessment | through study completion, an average of 36 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru Dai | Contact | +8615982215914 | dairu@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xianjie Wu | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University, China | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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.
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|
| Autologous Concentrated Growth Factor | Procedure |
|
|
| 5% minoxidil | Drug | topical 5% minoxidil, 1 ml, once daily |
|
| 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 |
| Grade of Ludwig and Norwood-Hamilton Classification | The Grade of Ludwig and Norwood-Hamilton Classification | week 12, 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 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
| D012046 | Rehabilitation |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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