Treatments of Striae Distensae
Conditions
Keywords
Striae Distensae, Platelet-Rich Plasma (PRP), Nanofat Graft, Microfat Graft, Combination Therapy
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.
Interventions
PROCEDUREPlatelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.
PROCEDURENanofat grafting
Nanofat grafting will be applied once every three months for 2 times.
PROCEDUREMicrofat grafting
Microfat grafting will be applied once every three months for 2 times.
Sponsors
Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.
First Affiliated Hospital of Jinan University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunohistochemical analysis | 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
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction assessments of participants: questionnaire | 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. |
Countries
China
Contacts
Primary ContactPik Nga Cheung, MD
Outcome results
None listed