The Combination Therapy of Nanofat Grafting and PRP Compared With Microfat Grafting and PRP Synergy in Treating Striae Distensae

January 16, 2019 updated by: Li-Ling Xiao, First Affiliated Hospital of Jinan University

The Combination Therapy of Nanofat Grafting and Platelet-Rich Plasma Injection Compared With Microfat Grafting and Platelet-Rich Plasma Injection Synergy in Treating Striae Distensae

Striae distensae is caused by the fracture and damage of the elastic fibers and collagen fibers, which is still a difficulty to overcome. Based on the studies demonstrated that platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat are effective in treating atrophic scar. So in this clinical trial, the investigators are going to treat striae distensae by using two combination therapies. One is nanofat grafting and PRP injection synergy, and the other one is treated by microfat grafting with PRP injection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The participants were randomly assigned into two groups. Group A is treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Group B will be treated by microfat grafting onceevery three months for 2 times combined with PRP injection once a month for 6 times. The participants were asked to come back 1、3、6、9 months after treatment for further follow-up.Before and after the treatment, the striae distensae will be assessed subjectively by satisfaction assessment, and objectively by ultrasound and immunohistochemical analysis.

Study Type

Interventional

Enrollment (Anticipated)

12

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 Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 500011
        • Recruiting
        • The First Affiliated Hospital of Jinan University
        • Contact:

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 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The striae distensae
  • Age ≤ 35 years old

Exclusion Criteria:

  • Skin allergy
  • Cicatricial diathesis
  • Skin inflammation or wound
  • Platelet dysfunction syndrome
  • Take anticoagulant drugs
  • Acute or chronic infection
  • Chronic liver disease
  • 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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nanofat grafting and PRP injection
Striae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
Procedure: Platelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.
Procedure: Nanofat grafting
Nanofat grafting will be applied once every three months for 2 times.
Experimental: Microfat grafting and PRP injection
Striae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
Procedure: Platelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.
Procedure: Microfat grafting
Microfat grafting will be applied once every three months for 2 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunohistochemical analysis
Time Frame: Change from baseline at 15 months.
The tissue extracted will be taken for immunohistochemical analysis to observe the amount of elastic fiber and collagen fiber,etc. More collagen fiber generated better outcome of the treatments.
Change from baseline at 15 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound
Time Frame: Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.
The striae distensae will be assessed by ultrasound in order to observe the change of dermal thickness of striae after the application of nanofat or microfat grafting with PRP injection. if the treatments worked, the dermal thickness will be increased.
Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.
Ultrasound
Time Frame: Change from baseline width of striae at 3,6,9,12,15 months of the treatments.
The striae distensae will be assessed by ultrasound in order to observe the change of width of striae after the application of nanofat or microfat grafting with PRP injection. Smaller the width better the results.
Change from baseline width of striae at 3,6,9,12,15 months of the treatments.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction assessments of participants: questionnaire
Time Frame: At 15th month.
The participants will fill in a questionnaire about the efficacy of the treatments. Participants will choose one of the following answers 'satisfied, unchanged, not satisfied' as feedback.
At 15th month.

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Jinan University

Collaborators

Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.

Investigators

  • Principal Investigator: Li Ling Xiao, MD, First Affiliated Hospital of Jinan University

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 (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xiao FirstJinanU

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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