Androgenic AlopeciaNCT03506503
Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
A study testing Nanofat grafting in people with Androgenic Alopecia, run by Jinan University Guangzhou at 1 site in China.
Trial summary
Nowadays, multiple treatment modalities have been applied clinically to treat androgenic alopecia, such as Follicular unit transplantation(FUT), finasteride, platelet-rich plasma injection(PRP), etc. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Nanofat grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2019to 1 May 2020
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients with androgenic alopecia aging from 18 to 50.
- No scars and wounds on the alopecia area.
- No skin disease or serious cardiovascular disease.
- Preoperative examinations remain healthy.
Who cannot join
- Serious chronic heart, liver, kidney, blood system disease
- Allergic diseases, skin inflammation or wounds
- Alopecia but not androgenic alopecia
- Acute or chronic infection
- Take anticoagulant drugs
- Active vitiligo, psoriasis, systemic lupus erythematosus
Trial locations and contacts
1 site in 1 country.
China1 site
the first affiliated hospital of Jinan University
Guangzhou, Guangdong, 510000
About this study
Nowadays, multiple treatment modalities have been applied clinically to treat androgenic alopecia, such as Follicular unit transplantation(FUT), finasteride, platelet-rich plasma injection(PRP), etc. In this clinical trial, the investigators aim to analyze the effect of nanofat grafting on treating androgenic alopecia in male.
Read the detailed description
The investigators will treat the hair loss area of a patient by processed nanofat grafting. The participants were asked to come back 1、3、6、9、12 months after treatment for further follow-up.
Before and after the treatment, the hair and follicular will be assessed subjectively by satisfaction assessment, dermatoscope.
- Conditions
- Androgenic Alopecia
- Being tested
- Nanofat grafting
- Keywords
- nanofat, hair loss, prp
- Medical subject headings
- Alopecia, Insomnia, Fatal Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanofat graftingProcedure or surgery
hair loss area will be treated by processed autologous Nanofat grafting
| Study group | Role | What they receive |
|---|---|---|
| processed Nanofat grafting | Experimental | processed autologous Nanofat will be injected into the area of the scalp with androgenic alopecia. Receives: Procedure: Nanofat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatoscope
the density of hair follicle and diameter of hair will be analized by dermatoscope before and after the treatment of Nanofat grafting.
Measured: Baseline and at1,3,6,9,12 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start27 Feb 2019
- Primary completion27 Feb 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Liu, Jinan University Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506503
- Sponsor's protocol ID
- 2019004
- Status last verified
- Feb 2021
- First submitted
- 14 Apr 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
PubMed 23783059Won CH, Park GH, Wu X, Tran TN, Park KY, Park BS, Kim DY, Kwon O, Kim KH. The Basic Mechanism of Hair Growth Stimulation by Adipose-derived Stem Cells and Their Secretory Factors. Curr Stem Cell Res Ther. 2017;12(7):535-543. doi: 10.2174/1574888X12666170829161058.
PubMed 28875863Gu Z, Li Y, Li H. Use of Condensed Nanofat Combined With Fat Grafts to Treat Atrophic Scars. JAMA Facial Plast Surg. 2018 Mar 1;20(2):128-135. doi: 10.1001/jamafacial.2017.1329.
PubMed 28975248
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT03506503
- Acronym / sponsor ID
- 2019004
- Conditions
- Androgenic Alopecia
- Keywords
- nanofat, hair loss, prp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 24 Apr 2018 (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.
Nowadays, multiple treatment modalities have been applied clinically to treat androgenic alopecia, such as Follicular unit transplantation(FUT), finasteride, platelet-rich plasma injection(PRP), etc. In this clinical trial, the investigators aim to analyze the effect of nanofat grafting on treating androgenic alopecia in male.
Detailed description
The investigators will treat the hair loss area of a patient by processed nanofat grafting. The participants were asked to come back 1、3、6、9、12 months after treatment for further follow-up.
Before and after the treatment, the hair and follicular will be assessed subjectively by satisfaction assessment, dermatoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| processed Nanofat grafting | Experimental | Procedure: Nanofat graftingprocessed autologous Nanofat will be injected into the area of the scalp with androgenic alopecia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male patients with androgenic alopecia aging from 18 to 50.
- No scars and wounds on the alopecia area.
- No skin disease or serious cardiovascular disease.
- Preoperative examinations remain healthy.
Key exclusion criteria (6 listed)
- Serious chronic heart, liver, kidney, blood system disease
- Allergic diseases, skin inflammation or wounds
- Alopecia but not androgenic alopecia
- Acute or chronic infection
- Take anticoagulant drugs
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 |
|---|---|---|
| Nanofat graftinghair loss area will be treated by processed autologous Nanofat grafting | Procedure or surgery | processed Nanofat grafting |
Primary outcome
Dermatoscope
Time frame: Baseline and at1,3,6,9,12 months after the treatment
the density of hair follicle and diameter of hair will be analized by dermatoscope before and after the treatment of Nanofat grafting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 23783059Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
- Background: PubMed 28875863Won CH, Park GH, Wu X, Tran TN, Park KY, Park BS, Kim DY, Kwon O, Kim KH. The Basic Mechanism of Hair Growth Stimulation by Adipose-derived Stem Cells and Their Secretory Factors. Curr Stem Cell Res Ther. 2017;12(7):535-543. doi: 10.2174/1574888X12666170829161058.
- Background: PubMed 28975248Gu Z, Li Y, Li H. Use of Condensed Nanofat Combined With Fat Grafts to Treat Atrophic Scars. JAMA Facial Plast Surg. 2018 Mar 1;20(2):128-135. doi: 10.1001/jamafacial.2017.1329.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanofat grafting in people with Androgenic Alopecia, run by Jinan University Guangzhou 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 21 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatoscope (time frame: Baseline and at1,3,6,9,12 months after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506503, which also lists 3 linked publications.
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 21 Feb 2021.