Treatments of Striae Distensae Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 12 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | May 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 35 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| First Affiliated Hospital of Jinan University | Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd. |
China,
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. 2018 Oct 22. doi: 10.1111/srt.12645. [Epub ahead of print] — View Citation
Forbat E, Al-Niaimi F. Treatment of striae distensae: An evidence-based approach. J Cosmet Laser Ther. 2018 Feb 16:1-9. doi: 10.1080/14764172.2017.1418515. [Epub ahead of print] — View 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. Review. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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. | |
| Primary | 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. | |
| Secondary | 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. | |
| Secondary | 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. |