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Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506503
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Hongwei Liu, Jinan University Guangzhou

Study Description
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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.

Condition or disease Intervention/treatment Phase
Androgenic Alopecia Procedure: Nanofat grafting Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
Actual Study Start Date : February 27, 2019
Actual Primary Completion Date : February 27, 2020
Actual Study Completion Date : May 1, 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Satisfaction assessments [ Time Frame: 1,3,6,12 months after treatment ]
    the satisfaction will be assessed after the treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506503


Locations
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China, Guangdong
the first affiliated hospital of Jinan University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Jinan University Guangzhou
More Information
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Publications:

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Responsible Party: Hongwei Liu, professor, Jinan University Guangzhou
ClinicalTrials.gov Identifier: NCT03506503    
Other Study ID Numbers: 2019004
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongwei Liu, Jinan University Guangzhou:
nanofat
hair loss
prp
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical