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NCT03328871 Clinical Trial

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

Treatments of Striae Gravidarum Clinical Trial

Official title:
The Combination Therapy of Fractional Laser and Platelet-Rich Plasma Injection Compared With Nanofat Grafting and Platelet-Rich Plasma Synergy in Treating Striae Gravidarum.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03328871
Other study ID # LXiao FirstJinanU
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2017
Est. completion date November 1, 2018

Study information
Verified date May 2018
Source First Affiliated Hospital of Jinan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date November 1, 2018
Est. primary completion date December 14, 2017
Accepts healthy volunteers No
Gender Female
Age group N/A to 35 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Fractional CO2 Laser
Fractional Carbon Dioxide Laser will be treated once every three months for 2 times.
Procedure:
• Nanofat grafting
Nanofat grafting will be applied once every three months for 2 times.
• Platelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.

Locations
Country Name City State
China First Affiliated Hospital of Jinan University Guangzhou Guangdong

Sponsors (2)
Lead Sponsor Collaborator
First Affiliated Hospital of Jinan University Science and Technology Program of Guangzhou

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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):931-9. doi: 10.1097/PRS.0000000000001705. — View Citation

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. — View Citation

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. — View Citation

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):1017-26. doi: 10.1097/PRS.0b013e31829fe1b0. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other 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.
Primary 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.
Secondary 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.
Secondary 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. Baseline and at 3,6,9,12,15 months after the treatments.

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