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| Name | Class |
|---|---|
| Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd. | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanofat grafting and PRP injection | Experimental | 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. |
|
| Microfat grafting and PRP injection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanofat grafting | Procedure | Nanofat grafting will be applied once every three months for 2 times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline at 15 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction assessments of participants: questionnaire | 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. | At 15th month. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pik Nga Cheung, MD | Contact | +8613631394662 | cheungpiknga@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Ling Xiao, MD | First Affiliated Hospital of Jinan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jinan University | Recruiting | Guangzhou | Guangdong | 500011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9747352 | Background | 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. | |
| 30345576 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2019 |
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| Microfat grafting | Procedure | Microfat grafting will be applied once every three months for 2 times. |
|
| Platelet-rich plasma (PRP) Injection | Procedure | PRP Injection will be applied once a month for 6 times. |
|
| 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. | Change from baseline width of striae at 3,6,9,12,15 months of the treatments. |
| 29451986 | Background | 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. |
| 28551068 | Background | 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. |
| Jan 16, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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