The Combination Therapy of Fractional Laser and PRP Compared With Nanofat Grafting and PRP Synergy in Treating Striae Gravidarum.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fractional CO2 Laser and PRP injection 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
Fractional Carbon Dioxide Laser will be treated once every three months for 2 times.
Procedure: Platelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.
|
| Experimental: Nanofat grafting and 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
Nanofat grafting will be applied once every three months for 2 times.
Procedure: Platelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.
|
Outcome Measures
Primary Outcome Measures
- Immunohistochemical analysis [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 Outcome Measures
- Dermatoscope [Baseline 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.
- Ultrasound [Baseline 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.
Other Outcome Measures
- Satisfaction assessments [After every sessions of treatments, and at 6,9,12,15 months.]
The participants, investigators and physicians will fill in a satisfaction assessment about any complication during the treatments.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The striae gravidarum was appeared within 3 years
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Age ≤ 35 years old
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Not in lactation
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Not pregnancy within one year
Exclusion Criteria:
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Skin allergy
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Skin inflammation or wound
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Platelet dysfunction syndrome
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Take anticoagulant drugs
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Acute or chronic infection
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Chronic liver disease
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Photodermatosis
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Active vitiligo, psoriasis, systemic lupus erythematosus
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Other clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | China | 500011 |
Sponsors and Collaborators
- First Affiliated Hospital of Jinan University
- Science and Technology Program of Guangzhou
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
- Cervelli V, Nicoli F, Spallone D, Verardi S, Sorge R, Nicoli M, Balzani A. Treatment of traumatic scars using fat grafts mixed with platelet-rich plasma, and resurfacing of skin with the 1540 nm nonablative laser. Clin Exp Dermatol. 2012 Jan;37(1):55-61. doi: 10.1111/j.1365-2230.2011.04199.x.
- Kamakura T, Kataoka J, Maeda K, Teramachi H, Mihara H, Miyata K, Ooi K, Sasaki N, Kobayashi M, Ito K. Platelet-Rich Plasma with Basic Fibroblast Growth Factor for Treatment of Wrinkles and Depressed Areas of the Skin. Plast Reconstr Surg. 2015 Nov;136(5):931-939. doi: 10.1097/PRS.0000000000001705.
- Kim IS, Park KY, Kim BJ, Kim MN, Kim CW, Kim SE. Efficacy of intradermal radiofrequency combined with autologous platelet-rich plasma in striae distensae: a pilot study. Int J Dermatol. 2012 Oct;51(10):1253-8. doi: 10.1111/j.1365-4632.2012.05530.x.
- Mehryan P, Zartab H, Rajabi A, Pazhoohi N, Firooz A. Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles. J Cosmet Dermatol. 2014 Mar;13(1):72-8. doi: 10.1111/jocd.12072.
- Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
- LXiao FirstJinanU