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

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

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.

Study Overview

• Status: Unknown
• Conditions: Treatments of Striae Gravidarum
• Intervention / Treatment: Device: Fractional CO2 Laser; Procedure: Platelet-rich plasma (PRP) Injection; Procedure: Nanofat grafting

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 500011
      • First Affiliated Hospital of Jinan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Platelet-rich plasma (PRP) Injection; PRP Injection will be applied once a month for 6 times.; Procedure: Nanofat grafting; Nanofat grafting will be applied once every three months for 2 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Other Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Jinan University
• Collaborators: Science and Technology Program of Guangzhou

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 14, 2017
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: October 29, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Platelet-Rich Plasma (PRP); Striae Gravidarum; Fractional Laser; Nanofat Graft; Combination Therapy
• Additional Relevant MeSH Terms: Skin Manifestations; Striae Distensae
• Other Study ID Numbers: LXiao FirstJinanU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No