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| Name | Class |
|---|---|
| Science and Technology Program of Guangzhou | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional CO2 Laser and PRP injection | Experimental | 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. |
|
| Nanofat grafting and PRP injection | Experimental | Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional CO2 Laser | Device | Fractional Carbon Dioxide Laser will be treated once every three months for 2 times. |
|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction assessments | The participants, investigators and physicians will fill in a satisfaction assessment about any complication during the treatments. | After every sessions of treatments, and at 6,9,12,15 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | 500011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22182435 | Background | 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. | |
| 26171752 | Background |
| Label | URL |
|---|---|
| Treatment of traumatic scars using fat grafts mixed with platelet-rich plasma, and resurfacing of skin with the 1540 nm nonablative laser. | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2017 |
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| Nanofat grafting | Procedure | Nanofat grafting will be applied once every three months for 2 times. |
|
| Platelet-rich plasma (PRP) Injection | Procedure | PRP Injection will be applied once a month for 6 times. |
|
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. |
| 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. |
| 24641609 | Background | 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. |
| 22994672 | Background | 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. |
| 23783059 | Background | 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. |
| Platelet-Rich Plasma with Basic Fibroblast Growth Factor for Treatment of Wrinkles and Depressed Areas of the Skin. | View source |
| Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles. | View source |
| Efficacy of intradermal radiofrequency combined with autologous platelet-rich plasma in striae distensae: a pilot study. | View source |
| Nanofat grafting: basic research and clinical applications. | View source |
| Oct 21, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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