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

Not Applicable

• Conditions: Treatments of Striae Distensae
• Interventions: Procedure: Microfat grafting; Procedure: Nanofat grafting; Procedure: Platelet-rich plasma (PRP) Injection

• Registration Number: NCT03807986
• Lead Sponsor: First Affiliated Hospital of Jinan University

Brief Summary

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.

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-16
• Last Update Submitted: 2019-01-16
• Study First Posted: 2019-01-17
• Last Update Posted: 2019-01-17
• Study Start: 2019-02-01
• Primary Completion: 2019-05-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Microfat grafting and PRP injection	Microfat grafting	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.
Nanofat grafting and PRP injection	Nanofat grafting	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.
Microfat grafting and PRP injection	Platelet-rich plasma (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.
Nanofat grafting and PRP injection	Platelet-rich plasma (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.

Primary Outcome Measures

Name	Time	Method
Immunohistochemical analysis	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.

Secondary Outcome Measures

Name	Time	Method
Ultrasound	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China