Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia

February 17, 2021 updated by: Hongwei Liu, Jinan University Guangzhou
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Jinan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: processed Nanofat grafting
processed autologous Nanofat will be injected into the area of the scalp with androgenic alopecia.
Procedure: Nanofat grafting
hair loss area will be treated by processed autologous Nanofat grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at1,3,6,9,12 months after the treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction assessments
Time Frame: 1,3,6,12 months after treatment
the satisfaction will be assessed after the treatment
1,3,6,12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinan University Guangzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2019

Primary Completion (Actual)

February 27, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

April 14, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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