Clinical trial NCT03807986: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Treatments of Striae Distensae
Keywords: Striae Distensae
Platelet-Rich Plasma (PRP)
Nanofat Graft
Microfat Graft
Combination Therapy
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
Collaborators: name: Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.
First posted: 2019-01-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Immunohistochemical analysis
timeFrame: Change from baseline at 15 months.
Secondary outcomes:
measure: Ultrasound
timeFrame: Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.
measure: Ultrasound
timeFrame: Change from baseline width of striae at 3,6,9,12,15 months of the treatments.
Other outcomes:
measure: Satisfaction assessments of participants: questionnaire
timeFrame: At 15th month.
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital of Jinan University
name: Li Ling Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.