NCT03506503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

February 27, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

April 14, 2018

Last Update Submit

February 17, 2021

Conditions

Keywords

nanofathair lossprp

Outcome Measures

Primary Outcomes (1)

  • Dermatoscope

    the density of hair follicle and diameter of hair will be analized by dermatoscope before and after the treatment of Nanofat grafting.

    Baseline and at1,3,6,9,12 months after the treatment

Other Outcomes (1)

  • Satisfaction assessments

    1,3,6,12 months after treatment

Study Arms (1)

processed Nanofat grafting

EXPERIMENTAL

processed autologous Nanofat will be injected into the area of the scalp with androgenic alopecia.

Procedure: Nanofat grafting

Interventions

hair loss area will be treated by processed autologous Nanofat grafting

processed Nanofat grafting

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Jinan University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (3)

  • 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.

    PMID: 23783059BACKGROUND
  • 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.

    PMID: 28875863BACKGROUND
  • 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.

    PMID: 28975248BACKGROUND

MeSH Terms

Conditions

AlopeciaInsomnia, Fatal Familial

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPrion DiseasesCentral Nervous System InfectionsInfectionsCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesSleep Initiation and Maintenance DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 14, 2018

First Posted

April 24, 2018

Study Start

February 27, 2019

Primary Completion

February 27, 2020

Study Completion

May 1, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations