The Combination Therapy of Fractional Laser and Platelet-Rich Plasma Injection Compared With Nanofat Grafting and Platelet-Rich Plasma Synergy in Treating Striae Gravidarum.
Overview
- Phase
- Phase 3
- Sponsor
- First Affiliated Hospital of Jinan University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Immunohistochemical analysis
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 35 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Immunohistochemical analysis
Time Frame: Baseline 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 Outcomes
- Ultrasound(Baseline and at 3,6,9,12,15 months after the treatments.)
- Dermatoscope(Baseline and at 3,6,9,12,15 months after the treatments.)
Investigators
Li-Ling Xiao
Associate Chief of Department of Plastic Surgery,The First Affiliated Hospital of Jinan University, Guangzhou
First Affiliated Hospital of Jinan University