Back to results

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

Primary Purpose

Treatments of Striae Distensae

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Nanofat grafting

Microfat grafting

Platelet-rich plasma (PRP) Injection

About this trial

This is an interventional treatment trial for Treatments of Striae Distensae focused on measuring Striae Distensae, Platelet-Rich Plasma (PRP), Nanofat Graft, Microfat Graft, Combination Therapy

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The First Affiliated Hospital of Jinan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Nanofat grafting and PRP injection

Microfat grafting and PRP injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Immunohistochemical analysis

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

Ultrasound

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.

Ultrasound

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.

Full Information

NCT ID

NCT03807986

First Posted

January 2, 2019

Last Updated

January 16, 2019

Sponsor

First Affiliated Hospital of Jinan University

Collaborators

Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03807986

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2019 (Anticipated)

Primary Completion Date

May 1, 2019 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Jinan University

Collaborators

Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatments of Striae Distensae

Keywords

Striae Distensae, Platelet-Rich Plasma (PRP), Nanofat Graft, Microfat Graft, Combination Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nanofat grafting and PRP injection

Arm Type

Experimental

Arm Description

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.

Arm Title

Microfat grafting and PRP injection

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Nanofat grafting

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Microfat grafting

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Platelet-rich plasma (PRP) Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Immunohistochemical analysis

Description

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.

Time Frame

Change from baseline at 15 months.

Secondary Outcome Measure Information:

Title

Ultrasound

Description

Time Frame

Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.

Title

Ultrasound

Description

Time Frame

Change from baseline width of striae at 3,6,9,12,15 months of the treatments.

Other Pre-specified Outcome Measures:

Title

Satisfaction assessments of participants: questionnaire

Description

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.

Time Frame

At 15th month.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pik Nga Cheung, MD

Phone

+8613631394662

cheungpiknga@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Ling Xiao, MD

Organizational Affiliation

First Affiliated Hospital of Jinan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Jinan University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

500011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pik Nga Cheung, MD

Phone

+8613631394662

cheungpiknga@126.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

9747352

Citation

Watson RE, Parry EJ, Humphries JD, Jones CJ, Polson DW, Kielty CM, Griffiths CE. Fibrillin microfibrils are reduced in skin exhibiting striae distensae. Br J Dermatol. 1998 Jun;138(6):931-7. doi: 10.1046/j.1365-2133.1998.02257.x.

Results Reference

background

PubMed Identifier

30345576

Citation

Cho C, Cho E, Kim N, Shin J, Woo S, Lee J, Lee J, Lee E, Ha J. Biophysical properties of striae rubra and striae alba in human skin: Comparison with normal skin. Skin Res Technol. 2019 May;25(3):283-288. doi: 10.1111/srt.12645. Epub 2018 Oct 22.

Results Reference

background

PubMed Identifier

29451986

Citation

Forbat E, Al-Niaimi F. Treatment of striae distensae: An evidence-based approach. J Cosmet Laser Ther. 2019;21(1):49-57. doi: 10.1080/14764172.2017.1418515. Epub 2018 Feb 16.

Results Reference

background

PubMed Identifier

28551068

Citation

Hague A, Bayat A. Therapeutic targets in the management of striae distensae: A systematic review. J Am Acad Dermatol. 2017 Sep;77(3):559-568.e18. doi: 10.1016/j.jaad.2017.02.048. Epub 2017 May 24.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs