Back to resultsCondensed Nanofat Grafting for Treatment of Androgenetic Alopecia
Primary Purpose
Androgenic Alopecia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nanofat grafting
Sponsored by
About this trial
This is an interventional treatment trial for Androgenic Alopecia focused on measuring nanofat, hair loss, prp
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- the first affiliated hospital of Jinan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
processed Nanofat grafting
Arm Description
processed autologous Nanofat will be injected into the area of the scalp with androgenic alopecia.
Outcomes
Primary Outcome Measures
Dermatoscope
the density of hair follicle and diameter of hair will be analized by dermatoscope before and after the treatment of Nanofat grafting.
Secondary Outcome Measures
Full Information
NCT ID
NCT03506503
First Posted
April 14, 2018
Last Updated
February 17, 2021
Sponsor
Jinan University Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT03506503
Brief Title
Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
Official Title
Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinan University Guangzhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
Keywords
nanofat, hair loss, prp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
processed Nanofat grafting
Arm Type
Experimental
Arm Description
processed autologous Nanofat will be injected into the area of the scalp with androgenic alopecia.
Intervention Type
Procedure
Intervention Name(s)
Nanofat grafting
Intervention Description
hair loss area will be treated by processed autologous Nanofat grafting
Primary Outcome Measure Information:
Title
Dermatoscope
Description
the density of hair follicle and diameter of hair will be analized by dermatoscope before and after the treatment of Nanofat grafting.
Time Frame
Baseline and at1,3,6,9,12 months after the treatment
Other Pre-specified Outcome Measures:
Title
Satisfaction assessments
Description
the satisfaction will be assessed after the treatment
Time Frame
1,3,6,12 months after treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
the first affiliated hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23783059
Citation
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.
Results Reference
background
PubMed Identifier
28875863
Citation
Won 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.
Results Reference
background
PubMed Identifier
28975248
Citation
Gu 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.
Results Reference
background
Learn more about this trial
Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
We'll reach out to this number within 24 hrs