Androgenetic AlopeciaNCT06218394
Comparison of Microneedling vs. Autologous Concentrated Growth Factor for the Treatment of Female Androgenetic Alopecia
A study testing microneedling, Autologous Concentrated Growth Factor and 5% minoxidil in people with Androgenetic Alopecia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- microneedling, Autologous Concentrated Growth Factor and 5% minoxidil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Ru Dai, Ph.D, 86 15982215914, dairu@zju.edu.cn
About this study
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).
Read the 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
- Being tested
- microneedling, Autologous Concentrated Growth Factor, 5% minoxidil
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedlingProcedure or surgery
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 FactorProcedure or surgery
- 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.
5% minoxidilDrug
topical 5% minoxidil, 1 ml, once daily
| Study group | Role | What they receive |
|---|---|---|
| microneedling | Experimental | Not described Receives: Procedure: microneedling |
| autologous concentrated growth factor | Experimental | Not described Receives: Procedure: Autologous Concentrated Growth Factor |
| 5% minoxidil | Active comparator | Not described Receives: Drug: 5% minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAHC
Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .
Measured: week 24
Secondary outcomes (6)
HGQA
Hair growth questionnaire assessment
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: week 8, week 12, week 16, week 24, week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start14 Dec 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xianjie Wu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218394
- Sponsor's protocol ID
- 20230984
- Status last verified
- Dec 2023
- First submitted
- 2 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Microneedling vs. Autologous Concentrated Growth Factor for the Treatment of Female Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT06218394
- Acronym / sponsor ID
- 20230984
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| microneedling | Experimental | Procedure: microneedling |
| autologous concentrated growth factor | Experimental | Procedure: Autologous Concentrated Growth Factor |
| 5% minoxidil | Active comparator | Drug: 5% minoxidil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microneedlingThe 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. | Procedure or surgery | microneedling |
| Autologous Concentrated Growth Factor1. 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. | Procedure or surgery | autologous concentrated growth factor |
| 5% minoxidiltopical 5% minoxidil, 1 ml, once daily | Drug | 5% minoxidil |
Primary outcome
TAHC
Time frame: week 24
Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .
6 secondary outcomes
HGQA
Time frame: week 8, week 12, week 16, week 24, week 36
TAHC
Time frame: week 8, week 12, week 20, week 36
TAHW
Time frame: week 8, week 12, week 16, week 24, week 36
IGA
Time frame: week 8, week 12, week 16, week 24, week 36
Grade of Ludwig and Norwood-Hamilton Classification
Time frame: week 12, week 24, week 36
SSA
Time frame: week 8, week 12, week 16, week 24, week 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianjie Wu principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microneedling, Autologous Concentrated Growth Factor and 5% minoxidil in people with Androgenetic Alopecia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru Dai (+8615982215914, dairu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAHC (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.