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

Phase 3
Conditions
Treatments of Striae Gravidarum
Interventions
Device: Fractional CO2 Laser
Procedure: Nanofat grafting
Procedure: Platelet-rich plasma (PRP) Injection
Registration Number
NCT03328871
Lead Sponsor
First Affiliated Hospital of Jinan University
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Fractional CO2 Laser and PRP injectionFractional CO2 LaserOne 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.
Nanofat grafting and PRP injectionPlatelet-rich plasma (PRP) InjectionAnother area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times.
Nanofat grafting and PRP injectionNanofat graftingAnother area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times.
Fractional CO2 Laser and PRP injectionPlatelet-rich plasma (PRP) InjectionOne 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.
Primary Outcome Measures
NameTimeMethod
Immunohistochemical analysisBaseline and 15 months.

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.

Secondary Outcome Measures
NameTimeMethod
UltrasoundBaseline and at 3,6,9,12,15 months after the treatments.

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.

DermatoscopeBaseline and at 3,6,9,12,15 months after the treatments.

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.

Trial Locations

Locations (1)

First Affiliated Hospital of Jinan University

🇨🇳

Guangzhou, Guangdong, China

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