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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Treatments of Striae Distensae

Intervention / Treatment
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* Procedure: Nanofat grafting
* Procedure: Microfat grafting
* Procedure: Platelet-rich plasma (PRP) Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanofat grafting and PRP injection<br>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: Nanofat grafting<br>* Nanofat grafting will be applied once every three months for 2 times.<br>Procedure: Platelet-rich plasma (PRP) Injection<br>* PRP Injection will be applied once a month for 6 times.<br>|
| Experimental: Microfat grafting and PRP injection<br>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: Microfat grafting<br>* Microfat grafting will be applied once every three months for 2 times.<br>Procedure: Platelet-rich plasma (PRP) Injection<br>* PRP Injection will be applied once a month for 6 times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemical analysis | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Striae Distensae, Platelet-Rich Plasma (PRP), Nanofat Graft, Microfat Graft, Combination Therapy