Clinical trial NCT03328871: The Combination Therapy of Fractional Laser and PRP Compared With Nanofat Grafting and PRP Synergy in Treating Striae Gravidarum.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Treatments of Striae Gravidarum
Keywords: Striae Gravidarum
Fractional Laser
Platelet-Rich Plasma (PRP)
Nanofat Graft
Combination Therapy
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
Collaborators: name: Science and Technology Program of Guangzhou
First posted: 2017-11-01
Enrollment: 10
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunohistochemical analysis
timeFrame: Baseline and 15 months.
Secondary outcomes:
measure: Dermatoscope
timeFrame: Baseline and at 3,6,9,12,15 months after the treatments.
measure: Ultrasound
timeFrame: Baseline and at 3,6,9,12,15 months after the treatments.
Other outcomes:
measure: Satisfaction assessments
timeFrame: After every sessions of treatments, and at 6,9,12,15 months.
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Jinan University
state: Guangdong
Study officials:
References:
citation: 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.
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):931-939. doi: 10.1097/PRS.0000000000001705.
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.
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.
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):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.