A Phase 3 interventional study of Fractional CO2 Laser and Nanofat grafting in Treatments of Striae Gravidarum, sponsored by First Affiliated Hospital of Jinan University. Status unknown at 1 site in China. Open to female participants aged Up to 35 Years. Per ClinicalTrials.gov, last updated 2018-05-25.
Sponsored by First Affiliated Hospital of Jinan University · Phase 3, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Striae Distensae; 7 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 43 interventional studies indexed under Striae Distensae.
Browse Striae Distensae studies →First Affiliated Hospital of Jinan University is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Procedure: Platelet-rich plasma (PRP) Injection
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 · Procedure: Platelet-rich plasma (PRP) Injection
Fractional Carbon Dioxide Laser will be treated once every three months for 2 times.
Nanofat grafting will be applied once every three months for 2 times.
PRP Injection will be applied once a month for 6 times.
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.
Time frame: Baseline and 15 months.
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.
Time frame: 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.
Time frame: Baseline and at 3,6,9,12,15 months after the treatments.
Satisfaction assessments
The participants, investigators and physicians will fill in a satisfaction assessment about any complication during the treatments.
Time frame: After every sessions of treatments, and at 6,9,12,15 months.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2017 to primary completion in Dec 2017, 8 months.
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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Jinan University