The Combination Therapy of Fractional Laser and PRP Compared With Nanofat Grafting and PRP Synergy in Treating Striae Gravidarum.

Study Overview
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Brief Summary
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Nowadays, multiple treatment modalities have been applied clinically to treat striae gravidarum, such as laser therapy, microdermabrasion, platelet-rich plasma injection(PRP), etc. To some extent, these treatments can improve striae gravidarum. In this clinical trial, the investigators are going to treat striae gravidarum by using two different kinds of combination therapies. One is fractional laser and PRP injection synergy, and the other one is treated by nanofat grafting with PRP injection.

Detailed Description
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The investigators will pick out two areas of most severe striae gravidarum on a participant's abdomen. One of the areas will be treated by fractional laser once every three months for 2 times combined with PRP injection once a month for 6 times. Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy 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 gravidarum will be assessed subjectively by satisfaction assessment, dermatoscope and ultrasound, and objectively by immunohistochemical analysis.

Official Title
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The Combination Therapy of Fractional Laser and Platelet-Rich Plasma Injection Compared With Nanofat Grafting and Platelet-Rich Plasma Synergy in Treating Striae Gravidarum.

Conditions
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Treatments of Striae Gravidarum

Intervention / Treatment
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* Device: Fractional CO2 Laser
* Procedure: Nanofat grafting
* Procedure: Platelet-rich plasma (PRP) Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The striae gravidarum was appeared within 3 years Age ≤ 35 years old Not in lactation Not pregnancy within one year Exclusion Criteria: Skin allergy Skin inflammation or wound Platelet dysfunction syndrome Take anticoagulant drugs Acute or chronic infection Chronic liver disease Photodermatosis Active vitiligo, psoriasis, systemic lupus erythematosus Other clinical trial

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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Female

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: Fractional CO2 Laser and PRP injection<br>One of the striae gravidarum areas will be treated by fractional laser once every three months for 2 times combined with PRP injection once a month for 6 times. | Device: Fractional CO2 Laser<br>* Fractional Carbon Dioxide Laser will be treated 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: Nanofat grafting and PRP injection<br>Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy 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>|

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 change of epidermal and dermal thickness, and the distribution and amount of elastic fiber and collagen fiber,etc. | Baseline and 15 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatoscope | The striae gravidarum will be assessed by dermatoscope to observe the pigmentation condition of striae after the application of laser or nanofat grafting with PRP injection. | Baseline and at 3,6,9,12,15 months after the treatments. | 
| Ultrasound | The striae gravidarum will be assessed by ultrasound in order to observe the change of dermal thickness of striae after the application of laser or nanofat grafting with PRP injection. | Baseline and at 3,6,9,12,15 months after the treatments. | 

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