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The Combination Therapy of Nanofat Grafting and PRP Compared With Microfat Grafting and PRP Synergy in Treating Striae Distensae

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ClinicalTrials.gov Identifier: NCT03807986
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.
Information provided by (Responsible Party):
Li-Ling Xiao, First Affiliated Hospital of Jinan University

Brief Summary:
Striae distensae is caused by the fracture and damage of the elastic fibers and collagen fibers, which is still a difficulty to overcome. Based on the studies demonstrated that platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat are effective in treating atrophic scar. So in this clinical trial, the investigators are going to treat striae distensae by using two combination therapies. One is nanofat grafting and PRP injection synergy, and the other one is treated by microfat grafting with PRP injection.

Condition or disease Intervention/treatment Phase
Treatments of Striae Distensae Procedure: Nanofat grafting Procedure: Microfat grafting Procedure: Platelet-rich plasma (PRP) Injection Not Applicable

Detailed Description:
The participants were randomly assigned into two groups. Group A is treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Group B will be treated by microfat grafting onceevery three months for 2 times combined with PRP injection 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 distensae will be assessed subjectively by satisfaction assessment, and objectively by ultrasound and immunohistochemical analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Combination Therapy of Nanofat Grafting and Platelet-Rich Plasma Injection Compared With Microfat Grafting and Platelet-Rich Plasma Injection Synergy in Treating Striae Distensae
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Nanofat grafting and PRP injection
Striae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
Procedure: Nanofat grafting
Nanofat grafting will be applied 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: Microfat grafting and PRP injection
Striae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
Procedure: Microfat grafting
Microfat grafting will be applied once every three months for 2 times.

Procedure: Platelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.




Primary Outcome Measures :
  1. Immunohistochemical analysis [ Time Frame: Change from baseline at 15 months. ]
    The tissue extracted will be taken for immunohistochemical analysis to observe the amount of elastic fiber and collagen fiber,etc. More collagen fiber generated better outcome of the treatments.


Secondary Outcome Measures :
  1. Ultrasound [ Time Frame: Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments. ]
    The striae distensae will be assessed by ultrasound in order to observe the change of dermal thickness of striae after the application of nanofat or microfat grafting with PRP injection. if the treatments worked, the dermal thickness will be increased.

  2. Ultrasound [ Time Frame: Change from baseline width of striae at 3,6,9,12,15 months of the treatments. ]
    The striae distensae will be assessed by ultrasound in order to observe the change of width of striae after the application of nanofat or microfat grafting with PRP injection. Smaller the width better the results.


Other Outcome Measures:
  1. Satisfaction assessments of participants: questionnaire [ Time Frame: At 15th month. ]
    The participants will fill in a questionnaire about the efficacy of the treatments. Participants will choose one of the following answers 'satisfied, unchanged, not satisfied' as feedback.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The striae distensae
  • Age ≤ 35 years old

Exclusion Criteria:

  • Skin allergy
  • Cicatricial diathesis
  • Skin inflammation or wound
  • Platelet dysfunction syndrome
  • Take anticoagulant drugs
  • Acute or chronic infection
  • Chronic liver disease
  • Active vitiligo, psoriasis, systemic lupus erythematosus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807986


Contacts
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Contact: Pik Nga Cheung, MD +8613631394662 cheungpiknga@126.com

Locations
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China, Guangdong
The First Affiliated Hospital of Jinan University Recruiting
Guangzhou, Guangdong, China, 500011
Contact: Pik Nga Cheung, MD    +8613631394662    cheungpiknga@126.com   
Sponsors and Collaborators
First Affiliated Hospital of Jinan University
Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.
Investigators
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Principal Investigator: Li Ling Xiao, MD First Affiliated Hospital of Jinan University
  Study Documents (Full-Text)

Documents provided by Li-Ling Xiao, First Affiliated Hospital of Jinan University:

Publications:
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Responsible Party: Li-Ling Xiao, Associate Chief of Department of Plastic Surgery, First Affiliated Hospital of Jinan University
ClinicalTrials.gov Identifier: NCT03807986     History of Changes
Other Study ID Numbers: Xiao FirstJinanU
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li-Ling Xiao, First Affiliated Hospital of Jinan University:
Striae Distensae
Platelet-Rich Plasma (PRP)
Nanofat Graft
Microfat Graft
Combination Therapy

Additional relevant MeSH terms:
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Striae Distensae
Skin Manifestations
Signs and Symptoms