The Combination Therapy of Fractional Laser and PRP Compared With Nanofat Grafting and PRP Synergy in Treating Striae Gravidarum.
Primary Purpose
Treatments of Striae Gravidarum
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fractional CO2 Laser
Nanofat grafting
Platelet-rich plasma (PRP) Injection
Sponsored by
About this trial
This is an interventional treatment trial for Treatments of Striae Gravidarum focused on measuring Striae Gravidarum, Fractional Laser, Platelet-Rich Plasma (PRP), Nanofat Graft, Combination Therapy
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
Sites / Locations
- First Affiliated Hospital of Jinan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fractional CO2 Laser and PRP injection
Nanofat grafting and PRP injection
Arm Description
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.
Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03328871
First Posted
September 26, 2017
Last Updated
May 23, 2018
Sponsor
First Affiliated Hospital of Jinan University
Collaborators
Science and Technology Program of Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT03328871
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 14, 2017 (Actual)
Study Completion Date
November 1, 2018 (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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatments of Striae Gravidarum
Keywords
Striae Gravidarum, Fractional Laser, Platelet-Rich Plasma (PRP), Nanofat Graft, Combination Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fractional CO2 Laser and PRP injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Nanofat grafting and PRP injection
Arm Type
Experimental
Arm Description
Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times.
Intervention Type
Device
Intervention Name(s)
Fractional CO2 Laser
Intervention Description
Fractional Carbon Dioxide Laser will be treated once every three months for 2 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)
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 change of epidermal and dermal thickness, and the distribution and amount of elastic fiber and collagen fiber,etc.
Time Frame
Baseline and 15 months.
Secondary Outcome Measure Information:
Title
Dermatoscope
Description
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.
Time Frame
Baseline and at 3,6,9,12,15 months after the treatments.
Title
Ultrasound
Description
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.
Time Frame
Baseline and at 3,6,9,12,15 months after the treatments.
Other Pre-specified Outcome Measures:
Title
Satisfaction assessments
Description
The participants, investigators and physicians will fill in a satisfaction assessment about any complication during the treatments.
Time Frame
After every sessions of treatments, and at 6,9,12,15 months.
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
500011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22182435
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.
Results Reference
background
PubMed Identifier
26171752
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.
Results Reference
background
PubMed Identifier
24641609
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.
Results Reference
background
PubMed Identifier
22994672
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.
Results Reference
background
PubMed Identifier
23783059
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.
Results Reference
background
Learn more about this trial
The Combination Therapy of Fractional Laser and PRP Compared With Nanofat Grafting and PRP Synergy in Treating Striae Gravidarum.
We'll reach out to this number within 24 hrs