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

NCT03328871 | Unknown Phase 3

• 1 other identifier: LXiao FirstJinanU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatments of Striae Gravidarum

Keywords

Striae Gravidarum; Fractional Laser; Platelet-Rich Plasma (PRP); Nanofat Graft; Combination Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dermatoscope

  Baseline and at 3,6,9,12,15 months after the treatments.

• Ultrasound

  Baseline and at 3,6,9,12,15 months after the treatments.

Other Outcomes (1)

• Satisfaction assessments

  After every sessions of treatments, and at 6,9,12,15 months.

Study Arms (2)

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.

Device: Fractional CO2 Laser; Procedure: Platelet-rich plasma (PRP) Injection

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.

Procedure: Nanofat grafting; Procedure: Platelet-rich plasma (PRP) Injection

Interventions

Fractional CO2 Laser DEVICE

Fractional Carbon Dioxide Laser will be treated once every three months for 2 times.

Fractional CO2 Laser and PRP injection

Nanofat grafting PROCEDURE

Nanofat grafting will be applied once every three months for 2 times.

Nanofat grafting and PRP injection

Platelet-rich plasma (PRP) Injection PROCEDURE

PRP Injection will be applied once a month for 6 times.

Fractional CO2 Laser and PRP injection; Nanofat grafting and PRP injection

Eligibility Criteria

• Age: Up to 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The striae gravidarum was appeared within 3 years
• Age ≤ 35 years old
• Not in lactation
• Not pregnancy within one year

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Jinan University: lead
• Science and Technology Program of Guangzhou: collaborator

Study Sites (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 500011, China

Location

Related 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.

  PMID: 22182435 BACKGROUND

• 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.

  PMID: 26171752 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.

  PMID: 24641609 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.

  PMID: 22994672 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.

  PMID: 23783059 BACKGROUND

Related Links

• Treatment of traumatic scars using fat grafts mixed with platelet-rich plasma, and resurfacing of skin with the 1540 nm nonablative laser.
• Platelet-Rich Plasma with Basic Fibroblast Growth Factor for Treatment of Wrinkles and Depressed Areas of the Skin.
• Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles.
• Efficacy of intradermal radiofrequency combined with autologous platelet-rich plasma in striae distensae: a pilot study.
• Nanofat grafting: basic research and clinical applications.

MeSH Terms

Conditions

Striae Distensae

Interventions

Injections

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Department of Plastic Surgery,The First Affiliated Hospital of Jinan University, Guangzhou

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: November 1, 2017
• Study Start: April 1, 2017
• Primary Completion: December 14, 2017
• Study Completion: November 1, 2018
• Last Updated: May 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)